MR x PIPELINE MRx AAVIEW & TRADITIONAL TRADITIONALDRUGS DRUGS VIEWINTO INTO UPCOMING UPCOMING SPECIALTY SPECIALTY &
JULY 2022 JANUARY 2022
Table of CONTENTS
EDITORIAL STAFF Maryam Tabatabai, PharmD Editor-in-Chief Vice President, Clinical Information Carole Kerzic, RPh Executive Editor Drug Information Pharmacist
EDITOR-IN-CHIEF'S MESSAGE
2
Consultant Panel
PIPELINE DEEP DIVE
3
Michelle Booth, PharmD Director, Specialty Clinical Solutions
KEEP ON YOUR RADAR
20
PIPELINE DRUG LIST
22
GLOSSARY
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40
Daphne Atria, PharmD, BCPS, CPE Strategic Clinical Pharmacist Consultant
Robert Greer, RPh, BCOP Vice President, Clinical Strategy and Programs Katie Lockhart Manager, Forecasting and Pharmacoeconomics Brian MacDonald, PharmD Director, Specialty Clinical Strategy Simone Ndujiuba, PharmD, BCOP Director, Clinical Strategy and Innovation, Oncology Nothing herein is or shall be construed as a promise or representation regarding past or future events and Magellan Rx Management expressly disclaims any and all liability relating to the use of or reliance on the information contained in this presentation. The information contained in this publication is intended for educational purposes only and should not be considered clinical, financial, or legal advice. By receipt of this publication, each recipient agrees that the information contained herein will be kept confidential and that the information will not be photocopied, reproduced, distributed to, or disclosed to others at any time without the prior written consent of Magellan Rx Management.
Editor-in-Chief's MESSAGE Welcome to the MRx Pipeline. This quarterly publication offers clinical insights and competitive intelligence on anticipated drugs in development, so you are well-sourced on the drug pipeline. MRx Pipeline, our universal forecast, addresses trends applicable across market segments. Traditional and specialty drugs as well as agents under the pharmacy and medical benefits are featured. Also profiled in the report are new molecular entities, pertinent new and expanded indications for existing medications, and biosimilars. Clinical analyses, financial outlook, and pre-regulatory status are considered. The products housed in the MRx Pipeline have been researched in detail. They have been developed in consultation with our internal team of clinical and analytics experts.
METHODOLOGY
Emerging therapeutics continue to grow and influence the clinical and financial landscape. Therefore, Magellan Rx Management has developed a systematic approach to determine the products with significant clinical impact. For the in-depth clinical evaluations, the products’ potential to meet an underserved need in the market by becoming the new standard of care, and the ability to replace existing therapies were investigated. The extent to which the pipeline drugs could shift market share on a formulary and their impact on disease prevalence were also important considerations. In order to assist payers with assessing the potential impact of these pipeline drugs, where available, a financial forecast has been included for select products. Primarily complemented by data from EvaluateTM, this pipeline report looks ahead at the 5-year projected annual US sales through the year 2026. These figures are not specific to a particular commercial or government line of business; rather, they look at forecasted total US sales. Depending on a variety of factors, including the therapeutic categories, eventual FDA-approved indications, populations within the plan, and other indices, the financial impact could vary by different lines of business.
REFLECTION
Thus far in 2022, the FDA has approved 16 novel drugs, about half the number of approvals compared to the same time last year. There continues to be a trend for drugs approved with at least 1 of the FDA’s expedited approval methods and drugs designated as Orphan Drugs. This year has also brought the FDA approval and authorization of COVID-19 vaccines as well as their expanded use in younger ages. In 2022 oral treatment options for COVID-19 received EUAs and the FDA authorized state-licensed pharmacists to prescribe the oral antiviral PaxlovidTM to eligible patients. While numbers do not tell the entire story, they do represent significant innovation in patient care and advance public health for the American public.
ON THE HORIZON
As we look ahead, there is a continued trend towards the approval of specialty medications and drugs for rare conditions, with 68% and 38% of approvals expected, respectively, for agents with applications submitted to the FDA. There are 4 agents seeking FDA’s Accelerated Approval, which allows for earlier drug approval for serious conditions that fill an unlet need based on a surrogate endpoint reasonably likely to predict a clinical benefit. New treatment modalities using gene therapy including for hemophila and the growth of biosimilars including interchangeable biosimilars are expected. Further, the launch of Humira® biosimilars in 2023 are highly anticipated. Other noteworthy pipeline trends to watch include the development of complex therapies, oncology, immunology, immunotherapy, new monoclonal antibodies for Alzheimer’s disease, and therapeutic options for rare hereditary diseases. Moreover, sprouting products for RSV, behavioral health including women’s mental health, and therapeutic psychedelics await on the horizon. The drug pipeline ecosphere will continue to evolve as it faces challenges and successes. Innovative agents that show positive results without compromising patient safety and access offer true therapeutic advances and hold the promise to alter the treatment paradigm Maryam Tabatabai, PharmD Editor-in-Chief, MRx Pipeline
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Pipeline DEEP DIVE Objective evidence-based methodology was used to identify the Deep Dive drugs in the upcoming quarters. This section features a clinical overview and explores the potential place in therapy for these agents. Moreover, it addresses their FDA approval timeline and 5-year financial forecast.
SPECIALTY
PRIORITY REVIEW
BREAKTHROUGH THERAPY
79%
21%
11%
BIOSIMILAR
ORPHAN DRUG
64%
18%
pecialty drug names appear in S magenta throughout the publication.
HEMATOLOGY
daprodustat oral GlaxoSmithKline PROPOSED INDICATIONS
Anemia of chronic kidney disease (CKD), dialysis- and non-dialysis dependent
CLINICAL OVERVIEW
Daprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF PHI). HIF PHIs stimulate erythropoietin production in the kidneys and liver, improve iron storage, and downregulate hepcidin – a key regulator of iron homeostasis. Two open-label, phase 3 trials evaluated daprodustat in patients with CKD-related anemia (Hb, 8 to 11.5 g/dL). In ASCEND-D (NCT02879305; n=2,964) patients on dialysis were randomized to oral daprodustat or an injectable ESA (epoetin alfa if on hemodialysis or darbepoetin alfa if on peritoneal dialysis). In ASCEND-ND (NCT03400033; n=3,872), patients not on dialysis were randomized to daprodustat or darbepoetin alfa. In both trials, daprodustat demonstrated non-inferiority to ESAs for the primary efficacy endpoint of the mean change in Hb from baseline to weeks 28 through 52 (ASCEND-D, 0.28 versus 0.1 g/dL, respectively [p<0.001]; ASCEND-ND, 0.74 versus 0.66 g/dL, respectively [p<0.001]). In both trials, daprodustat also demonstrated noninferiority to ESA therapy in the primary safety endpoint of rate of first occurrence of MACE (ASCEND-D, 25.2% versus 26.7%, respectively [p<0.001]; ASCEND-ND, 19.5% versus 19.2%, respectively [p=0.005]), during the 2.5 years of follow up in ASCEND-D and 1.9 years in ASCEND-ND. Non-inferiority of daprodustat relative to ESA therapy was also seen when MACE was expanded to include thrombotic events and hospitalization for HF. In both trials, ophthalmic complications, including proliferative retinopathy, occurred at similar rates between the treatment groups. In ASCEND-ND, daprodustat was associated with significantly higher rates of cancer-related death or tumor progression (3.7% versus 2.5%, respectively [p=0.04]) and esophageal/gastric erosions (3.6% versus 2.1%, respectively [p=0.005]) compared to ESAs; this was not seen in ASCEND-D.
PLACE IN THERAPY
An estimated 37 million (1 in 7) people in the US have CKD. The incidence varies according to population, including African Americans (16%), Hispanics (14%), Caucasians (13%), and Asians (13%). Anemia is prevalent in patients with CKD and worsens as CKD progresses. Anemia can lead to arrhythmia, cardiomegaly, and HF as well as fatigue and decreased QOL. Treatment with iron, vitamin B12 and folic acid supplementation, ESAs (epoetin alfa [Epoetin®, Procrit®, biosimilars], darbepoetin alfa [Aranesp®]), and RBC transfusions is used to manage anemia. However, transfusions can reduce the patient’s eligibility for kidney transplant and increase risk of infections, HF, allergic reactions, and iron overload. In addition, ESAs are associated with an increased risk of MACE and thromboembolism. If approved, daprodustat will be the first HIF PHI agent in the US for CKD-related anemia. Like ESAs, HIF PHIs are associated with increased CV and cancer risks. In clinical trials, daprodustat was non-inferior to ESAs in improving or maintaining Hb levels and showed no increase in CVD, including thrombosis, compared to ESA therapy. However, cancer-related death or tumor progression was more prevalent in non-dialysis patients treated with daprodustat than those given an ESA. Notably, as with other investigational HIF PHI agents, daprodustat did not slow the progression of CKD when compared to ESAs in clinical trials. Other HIF PHIs in phase 3 trials for CKD-related anemia include oral roxadustat and vadadustat. After previous submissions, both roxadustat and vadadustat received Complete Response Letters (CRLs) from the FDA requesting additional study data due to safety concerns (e.g., MACE, thromboembolic events, drug-induced liver injury).
FDA APPROVAL TIMELINE February 1, 2023
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$0
$58
$195
$535
$808
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HEMATOLOGY
etranacogene dezaparvovec IV CSL Behring PROPOSED INDICATIONS Hemophilia B
CLINICAL OVERVIEW
Etranacogene dezaparvovec (etrana-dez) is a recombinant adeno-associated viral vector of serotype 5 (AAV5) gene therapy containing a codon-optimized Padua gene variant human factor IX (FIX) transgene. Etrana-dez was evaluated in the open-label, single-arm, phase 3 HOPE-B trial (NCT03569891) in 54 adult males with moderately severe or severe hemophilia B, defined as having ≤ 2% of normal FIX activity. Patients enrolled required prophylactic FIX replacement therapy. Thirty-one patients had pre-existing AAV5-neutralizing antibodies (NAbs), while 23 did not. Etrana-dez led to a mean FIX activity of 39 IU/dL at 6 months after the dose and 36.9 IU/dL at 18 months post dose. Steady-state FIX transgene expression likely occurred during 7 to 18 months post dose. During this time, the adjusted annualized bleeding rate (ABR) decreased by 64% (p=0.0002) and all FIX-treated bleeds declined by 77% (p<0.0001). Notably, 98% of patients who received a full dose of etrana-dez discontinued prophylactic FIX replacement therapy. Etrana-dez was generally well tolerated, with no treatment-related deaths reported. FIX inhibitors were not detected. In addition, in a phase 2b study (NCT03489291), sustained FIX activity was demonstrated at 2 years in 3 patients who received the full dose of etrana-dez. The mean FIX activity was 44.2% of normal at 2 years. Etrana-dez was administered as a one-time dose of 2 x 1013 genome copies per kilogram (gc/kg) via IV infusion.
PLACE IN THERAPY
Hemophilia B is a rare genetic bleeding disorder caused by FIX gene mutations. In a subset of patients, hemophilia B is acquired after the production of FIX-directed antibodies in the body. Hemophilia B accounts for 20% of all hemophilia cases, while hemophilia A accounts for 80%. In hemophilia B, insufficient levels of FIX, a blood clotting protein, may result in prolonged bleeding. In moderate cases, FIX level is 1% to 5% of normal, and in severe cases, it is < 1% of normal. Bleeding symptoms may arise spontaneously or after a minor injury and can occur in the muscles, joints, organs, and brain. Incidence of hemophilia B is approximately 1 in 25,000 male births. The preferred treatment for hemophilia B is recombinant FIX therapy (Alprolix®, Benefix®, Idelvion®, Ixinity®, Rebinyn®, and Rixubis®). Other options include plasma-derived FIX concentrates (Alphanine SD®, Mononine®, and Profilnine SD®), plasma-derived activated prothrombin complex (Feiba®; for select patients with FIX inhibitors), and fresh frozen plasma. If approved, etrana-dez will be the first gene replacement DMT for the treatment of hemophilia B. In clinical trials, it produced a durable improvement in FIX activity after a single dose. Most patients treated with etranadez discontinued prophylactic FIX replacement therapy. The viral gene therapy fidanacogene elaparvovec by Pfizer/Roche is in phase 3 trials for hemophilia B, with data expected in Q1 2023.
FDA APPROVAL TIMELINE November 2022
Breakthrough Therapy
Orphan Drug
Priority Review
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$14
$91
$155
$236
$290
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ONCOLOGY
futibatinib oral Obseva PROPOSED INDICATIONS
Locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene rearrangements, including gene fusions
CLINICAL OVERVIEW
Futibatinib is a selective and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3, and 4. Futibatinib was evaluated in the single-arm, phase 2 FOENIX-CCA2 study (NCT02052778) in 103 patients with locally advanced or metastatic, unresectable, intrahepatic CCA with FGFR2 gene rearrangement, including fusions. Patients had received ≥ 1 prior systemic treatment (e.g., gemcitabine plus platinumbased chemotherapy). At a median follow-up of 25 months, the primary endpoint of ORR as assessed by independent central review was 41.7%. The study also reported a median PFS of 8.9 months, median OS of 20 months, median DOR of 9.5 months, and disease control rate of 82.5%. The most common TEAEs were of mild to moderate severity. These included alopecia, dry mouth, diarrhea, dry skin, and fatigue. No treatmentrelated deaths occurred. The phase 3, open-label FOENIX-CCA3 trial is underway comparing futibatinib with cisplatin plus gemcitabine chemotherapy as first-line treatment in patients with intrahepatic CCA. The futibatinib dosage was 20 mg orally once daily until disease progression or unacceptable toxicity.
PLACE IN THERAPY
CCAs originate in the bile duct epithelium. Approximately 8,000 cases are diagnosed each year in the US, with approximately 10% of those cases being intrahepatic CCA and 90% being extrahepatic CCA. The average age at diagnosis is 70 to 72 years. Five-year survival rates for localized, regional, and distant intrahepatic CCAs are 24%, 9%, and 2%, respectively, and for extrahepatic CCAs are 17%, 16%, and 2%, respectively. The only potential curative treatment for CCA is complete surgical resection. However, most patients are not surgical candidates since advanced disease is often found at initial diagnosis. According to the NCCN, primary treatment options for patients with unresectable or metastatic disease include: systemic chemotherapy (preferred gemcitabine plus cisplatin), enrollment in a clinical trial, or best supportive care. Fluoropyrimidine chemoradiation may also be used in patients with unresectable disease. If approved, futibatinib will be the third medication available to treat CCA that harbors FGFR2 gene rearrangements, following the oral kinase inhibitors infigratinib (Truseltiq®) and pemigatinib (Pemazyre®). Infigratinib and pemigatinib are indicated for unresectable intrahepatic and extrahepatic CCA. While the application to the FDA for approval of futibatinib for the treatment of CCA does not specify intrahepatic CCA only, the pivotal phase 2 trial only reports on its use in patients with unresectable intrahepatic CCA. Futibatinib is also in phase 2 trials for bladder cancer and solid tumors.
FDA APPROVAL TIMELINE September 30, 2022
Breakthrough Therapy
Orphan Drug
Priority Review
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$3
$16
$30
$48
$64
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NEUROLOGY
lecanemab IV Eisai/Biogen PROPOSED INDICATIONS
Early Alzheimer’s disease (AD) with confirmed presence of amyloid pathology in the brain
CLINICAL OVERVIEW
Lecanemab is an immunoglobulin G1 (lgG1) antibody that is designed to eliminate neurotoxic amyloid-beta (Aβ) protofibrils. Lecanemab was evaluated in the double-blind, placebo-controlled, phase 2, proof-of-concept Study 201 CORE trial (NCT01767311). It enrolled 856 individuals with early AD (mild cognitive impairment due to AD and mild AD dementia) with amyloid plaque detected by amyloid positron emission tomography (PET) or cerebral spinal fluid (CSF) Aβ1–42. At 12 months, based on a Bayesian adaptive analysis, the trial did not meet the primary endpoint of super-superiority to placebo as measured by the AD Composite Score (ADCOMS), which indicates a > 80% probability of > 25% slowing in cognitive decline. However, at 18 months, the study reported that lecanemab 10 mg/kg given IV every 2 weeks led to significant improvements in key secondary endpoints. These included a reduction of amyloid in the brain, based on an adjusted mean change from baseline by −0.3 in the PET standard update value ratio (SUVr) (mean baseline, 1.37). Slowing of cognitive decline by 30% based on ADCOMS, by 26% based on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), and by 47% based on the AD Assessment Scale–Cognitive Subscale (ADAS-cog) was also observed at 18 months. In addition, > 80% of individuals became amyloid negative (per visual read). The rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) was 9.9% with lecanemab (18.8% were symptomatic) compared to 0.8% with placebo during the first year of treatment.
PLACE IN THERAPY
AD is a neurodegenerative disorder characterized by cognitive and memory decline that is associated with impairment of ADLs and behavioral disturbances. It is the most common form of dementia. AD is estimated to affect over 5 million elderly people in the US, and its incidence is expected to nearly triple by 2060. The presence in the brain of amyloid plaque, as well as abnormalities of cholinergic, glutamate, and serotonin systems, are thought to contribute to the development of AD. Current pharmacotherapy for mild to moderate AD includes transdermal and/or oral acetylcholinesterase inhibitors (donepezil, galantamine, rivastigmine) and oral N-methyl-D-asparate (NMDA) receptor antagonists (memantine). A fixed-dose combination of donepezil and memantine is available for moderate to severe disease. In addition, the once-monthly IV amyloid betadirected antibody aducanumab-avwa (Aduhelm®) was granted an Accelerated Approval for early AD in June 2021. Its FDA-approval was met with significant controversy due to uncertainty of benefit. Moreover, CMS limited coverage of aducanumab-avwa to patients enrolled in clinical trials, and coverage of future anti-amyloids would also be restricted unless full approval is granted on the basis of confirmatory trials. Hence, results of the phase 3 CLARITY AD confirmatory trial, expected in fall 2022, will be central to the potential future of lecanemab. If approved, lecanemab will be the second amyloid-targeting DMT for early AD. In non-comparative clinical trials, ARIA-E, which may lead to dose interruption or treatment discontinuation, was reported less often with lecanemab (9.9%) than with aducanumab-avwa (35%). Other injectable anti-amyloid antibodies in late-stage development for AD include donanemab, gantenerumab, and solanezumab.
FDA APPROVAL TIMELINE January 6, 2023
Breakthrough Therapy
Fast Track
Priority Review
seeking Accelerated Approval
Eisai plans to submit for full approval by March 31, 2023.
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$0
$70
$241
$496
$762
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ONCOLOGY
mirvetuximab soravtansine IV Immunogen PROPOSED INDICATIONS
Ovarian cancer that is folate receptor alpha (FRα)-high platinum-resistant after 1 to 3 prior systemic treatments
CLINICAL OVERVIEW
Mirvetuximab soravtansine is an investigational ADC. It contains DM4, a tubulin-targeting cytotoxic maytansinoid, which is linked to a folate receptor alpha (FRα)-binding antibody. FORWARD-1 (NCT02631876) is an open-label, phase 3 trial in 366 women with platinum-resistant medium or high FRα-positive advanced epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer who had been treated with 1 to 3 prior systemic regimens. Women with ECOG status of 0 or 1 were randomized 2:1 to mirvetuximab soravtansine 6 mg/kg IV every 21 days or investigator’s choice chemotherapy (e.g., paclitaxel, pegylated liposomal doxorubicin, topotecan). After a median follow-up of 12. 5 months, mirvetuximab soravtansine did not lead to a significant difference over chemotherapy in the primary endpoint of PFS in either the ITT population (HR, 0.981; p=0.897) or the FRα high group (HR 0.693; p=0.049, not significant based on the Hochberg analysis protocol). For the FRα high population, nonsignificant improvements, as determined by the analysis protocol, were also reported in secondary endpoints, including OS (HR, 0.618) and ORR (22% versus 10% for mirvetuximab soravtansine versus chemotherapy, respectively). TEAEs included nausea, diarrhea, fatigue, blurred vision, keratopathy, and peripheral neuropathy. Fewer grade ≥ 3 TEAEs were reported with mirvetuximab than with chemotherapy (25.1% versus 44%, respectively). The phase 3, single-arm SORAYA trial evaluated mirvetuximab soravtansine in 106 patients with FRα high platinum-resistant EOC who had received 1 to 3 prior therapies, including bevacizumab. Per investigator assessment, at data cut-off, the primary endpoint of ORR was 32.4%, of which 5 cases were complete responses. The disease control rate was 51.4%, and tumor reduction was observed in 71.4% of patients. The median time to response was 1.5 months, median DOR was 6.9 months, median PFS was 4.3 months, and median OS was 13.8 months. The most common TEAEs were blurred vision, keratopathy, and nausea.
PLACE IN THERAPY
EOC accounts for approximately 90% of all malignant ovarian neoplasms. It is the major gynecologic cancer that leads to death, with a 5-year survival rate of 48%. Prognosis for many women, particularly those with advanced, recurrent, or resistant disease, remains poor. It is estimated that 19,880 new cases of EOC will be diagnosed and 12,810 related deaths will occur in the US in 2022. Treatment involves debulking surgery, followed by systemic chemotherapy (e.g., platinum- and taxanebased agents, ± bevacizumab [Avastin®, biosimilars]). An oral PARP inhibitor (e.g., niraparib [Zejula®], olaparib [Lynparza®], and rucaparib [Rubraca®]) may accompany maintenance chemotherapy. Notably, EOC tumors often become platinum-resistant, restricting further treatment options. FRα is found in over 80% of ovarian carcinomas and is associated with poorly-differentiated, aggressive tumors. Mirvetuximab soravtansine is a first-in-class FRα-targeting ADC. While it appears to be better tolerated than chemotherapy, mirvetuximab soravtansine demonstrated mixed results in treating platinumresistant EOC compared to standard chemotherapy. If approved, it will provide another treatment for women with limited options.
FDA APPROVAL TIMELINE November 28, 2022 Fast Track
Orphan Drug
Priority Review
seeking Accelerated Approval
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$10
$82
$166
$262
$353
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NEUROLOGY
omaveloxolone oral Reata/Abbvie PROPOSED INDICATIONS Friedreich’s ataxia (FA)
CLINICAL OVERVIEW
Omaveloxolone activates nuclear factor erythroid 2-related factor 2 (Nrf2), a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Part 2 of the double-blind, placebo-controlled, parallel-group, phase 2 MOXIe study (NCT02255435) evaluated omaveloxolone’s impact on neurological function in 103 patients with genetically confirmed FA. Enrolled patients were 16 to 40 years of age with a baseline modified FA Rating Scale (mFARS) between 20 and 80 points. The mFARS, the study’s primary endpoint, is a measure of neurologic severity of FA (range, 0 to 99 points) with higher scores representing worse neurological function. Patients were randomized 1:1 to omaveloxolone or placebo. After 48 weeks, there was a significant mean change from baseline in mFARS with omaveloxolone (−1.55 points) compared to placebo (0.85 points) (difference, –2.4; p=0.014). Omaveloxolone improved each component of the mFARS (bulbar, upper limb coordination, lower limb coordination, and upright stability) compared to placebo. Omaveloxolone was generally well tolerated. The most common TEAEs were headache, nausea, asymptomatic transient increases in ALT and AST, fatigue, diarrhea, and abdominal pain. The omaveloxolone dosage in part 2 of the MOXIe study was 150 mg orally once daily.
PLACE IN THERAPY
FA is a rare inherited disorder caused by a mutation in the FXN gene, leading to oxidative stress and a deficiency of the frataxin protein in the mitochondria. Progressive degeneration of spinal cord and peripheral nerves occurs, resulting in unsteady movements and impaired sensory functions. FA affects approximately 1 in 50,000 Americans. Patients with FA inherit 1 defective FXN gene from each parent. While pharmacologic and non-pharmacologic treatments exist for FA complications (e.g., diabetes, cardiac dysfunction, foot deformities, scoliosis, swallowing and speech dysfunction, hearing impairment), there is no cure or effective treatment for the neurologic effects of FA. In the MOXIe trial, omaveloxolone was well tolerated and demonstrated significant improvement in neurologic function compared to worsening neurologic function observed with placebo. If approved, omaveloxolone will be the first medication for the treatment of FA. Oral vatiquinone, by PTC Therapeutics, is also in phase 3 trials for FA. Like omaveloxolone, vatiquinone reduces oxidative stress and neuroinflammation.
FDA APPROVAL TIMELINE November 30, 2022 Fast Track
Orphan Drug
Priority Review
Rare Pediatric Disease
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$0
$44
$101
$186
$267
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CARDIOLOGY
omecamtiv mecarbil oral Cytokinetics PROPOSED INDICATIONS
Treatment of heart failure with reduced ejection fraction (HFrEF)
CLINICAL OVERVIEW
Omecamtiv mecarbil is a cardiac myosin activator. It increases the number of active actin-myosin cross bridges during systole and ultimately enhances the impaired contractility that is associated with HFrEF. Omecamtiv mecarbil was evaluated in the double-blind, placebo-controlled, phase 3 GALACTIC-HF trial (NCT02929329) in 8,256 patients with symptomatic (NYHA functional class II to IV) HFrEF and an ejection fraction (EF) < 35% within the past 12 months. When added to SOC, omecamtiv mecarbil significantly reduced the risk of the primary composite endpoint of HF event or CV death compared to placebo (HR, 0.92; p=0.025) in the overall study population. When stratified by EF, omecamtiv mecarbil-treated patients with an EF ≤ 28% experienced a 16% relative reduction in the time to first HF event or CV death (HR, 0.84; p=0.0003), while there was no significant change among those with an EF > 28% (HR, 1.04; p=0.45). In the randomized, double-blind, phase 3 METORIC-HF trial (NCT03759392), 20 weeks of treatment with omecamtiv mecarbil did not significantly impact the peak oxygen update (pVO2) compared to placebo in 276 patients with NYHA functional class II to III HFrEF and an LVEF < 35% who were also receiving SOC therapy. No benefit was demonstrated on total workload during exercise, ventilatory efficiency, or daily physical activity. The starting dose of omecamtiv mecarbil was 25 mg orally twice daily. This was titrated based on drug plasma concentrations to a maximum of 37.5 mg twice daily.
PLACE IN THERAPY
HF is a progressive condition caused by a change in cardiac function that results in a failure of the heart to deliver an adequate supply of oxygenated blood to the tissues. It is considered to be HFrEF when the EF is ≤ 40%. Coronary artery disease (CAD) is the cause of HF in nearly 70% of cases. Incidence of HF in the US is estimated to be 6.2 million individuals. Risks of HF-related hospitalization and death are higher among Blacks than Caucasians. Typical symptoms include dyspnea, fatigue, and fluid retention. An angiotensin receptor neprilysin inhibitor (ARNI) is the treatment of choice to decrease mortality and morbidity in patients with HFrEF, with ACEIs or ARBs as alternative medications in patients with NYHA class II to IV HFrEF. Other agents that may also be used are beta blockers, mineralocorticoid receptor antagonists, SGLT2 inhibitors, diuretics, ivabradine (Corlanor®), vericiguat (Verquvo®), digoxin, and isosorbide dinitrate. Omecamtiv mecarbil improves impaired systolic function, a key defect of HFrEF. In clinical trials, omecamtiv mecarbil led to greater therapeutic benefit with lower baseline EF in patients with HFrEF. If approved, it will be the first cardiac myosin activator in the US to treat HF.
FDA APPROVAL TIMELINE February 28, 2023
The Cardiovascular and Renal Drugs Advisory Committee will review omecamtiv mecarbil on December 13, 2022. Fast Track
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$0
$31
$90
$149
$221
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RENAL
sparsentan oral Travere/Bristol-Myers Squibb PROPOSED INDICATIONS
Immunoglobulin A (IgA) nephropathy (IgAN)
CLINICAL OVERVIEW
Sparsentan is a dual endothelin and angiotensin receptor antagonist (DEARA) designed to reduce proteinuria, protect podocytes, and prevent glomerulosclerosis and mesangial cell proliferation. The double-blind, active-controlled, phase 3 PROTECT study (NCT03762850) evaluated sparsentan in 404 adults with biopsy confirmed IgAN and persistent proteinuria despite treatment with an ACEI or ARB. Patients were randomized to sparsentan or irbesartan. At the 36-week interim analysis, sparsentan led to a significant mean reduction in proteinuria compared to irbesartan (49.8% versus 15.1%, respectively; p<0.0001). Sparsentan was generally well tolerated. Final data of the 114-week trial is expected in mid-2026. Sparsentan was administered orally as 200 mg once daily for 2 weeks; if tolerated, it was increased to 400 mg once daily.
PLACE IN THERAPY
IgAN, also known as Berger’s disease, is an autoimmune disorder characterized by the accumulation of IgA in the kidneys. This causes inflammation and damage to the glomeruli of the kidneys and may eventually lead to ESRD. IgAN is one of the most common causes of glomerulonephritis. IgAN can occur at any age, but onset is typically seen between the teen years to late 30s. The incidence is 2-fold higher in men than women. It is also more common among Asians and Caucasians. IgAN is estimated to occur in about 60,000 Americans. Pharmacologic treatment of IgAN is focused on preventing or delaying ESRD with antihypertensive medications, such as ACEIs, ARBs, beta blockers, and calcium channel blockers. Corticosteroids, immunosuppressive agents, an SGLT2 inhibitor, and/or fish oil may be added in patients with persistent proteinuria (≥ 1 g/day) who are at increased risk for progression to ESRD. Kidney transplantation is the treatment of choice in patients who progress to kidney failure; however, recurrent IgA accumulation is common. Currently, delayed-release oral budesonide (Tarpeyo™) is the only medication FDA-approved to reduce proteinuria in adults with primary IgAN. If approved, sparsentan will be the first non-immunosuppressive option to treat IgAN. In the pivotal clinical trial, it led to a significantly greater improvement in proteinuria compared to ARB therapy. Several other agents with various mechanisms of action are in phase 3 trials for IgAN. They include atrasentan (endothelin A receptor antagonist), iptacopan (factor B inhibitor of the alternative complement pathway), narsoplimab (anti-mannan-associated lectin-binding serine protease−2 monoclonal antibody), and VIS649 (anti-A proliferation-inducing ligand monoclonal antibody). Sparsentan is also in phase 3 trials for focal segmental glomerulosclerosis.
FDA APPROVAL TIMELINE November 17, 2022 Orphan Drug
Priority Review
seeking Accelerated Approval
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$1
$40
$150
$258
$351
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NEUROLOGY
zavegepant intranasal Biohaven/Bristol-Myers Squibb PROPOSED INDICATIONS
Acute treatment of migraine in adults
CLINICAL OVERVIEW
Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. Zavegepant was evaluated in 2 randomized, double-blind, placebo-controlled, phase 3 trials (study 1 [NCT04571060], study 2 [NCT03872453]) in adults experiencing a moderate to severe migraine attack. Patients had a history of 2 to 8 migraine attacks per month. In study 1 (n=1,269 evaluable patients), zavegepant 10 mg was superior to placebo based on the co-primary endpoints of freedom from pain 2 hours after the dose (2hPF) (23.6% versus 14.9%, respectively; p=0.0001) and freedom from the most bothersome symptom (MBS) (e.g., photophobia, phonophobia) 2 hours after the dose (2hMBSF) (39.6% versus 31.1%, respectively; p=0.0012). In addition, significantly more patients experienced pain relief with zavegepant than with placebo at 15 minutes post dose (15.9% versus 8%, respectively; p<0.0001). After the dose, more patients were able to return to normal function with zavegepant than with placebo at 30 minutes (10.5% versus 6.1%, respectively; p=0.0059) and 2 hours (35.8% versus 25.6%, respectively; p=0.0001). In study 2 (n=1,673), zavegepant 10 mg and 20 mg doses were superior to placebo based on the proportion of patients who experienced 2hPF (22.5% [p=0.112] and 23.1% [p=0.0055], respectively, versus 15.5%) and 2hMBSF (41.9% [p=0.0155] and 42.5% [p=0.0094], respectively, versus 33.7%). The most common TEAEs were mild to moderate dysgeusia, nasal discomfort, and nausea. Zavegepant was administered as a single intranasal dose to treat 1 migraine attack.
PLACE IN THERAPY
Migraine affects over 37 million men, women, and children in the US. Three times more women than men experience migraines and the majority of migraine sufferers have a family history of the condition. Migraines are considered a leading cause of disability worldwide. Episodes can be debilitating with pain that lasts hours to days. Triptans are the SOC for the acute treatment of moderate to severe migraine episodes. Oral small molecule CGRP inhibitors are also approved for acute treatment of migraine in adults and include rimegepant (Nurtec® ODT) and ubrogepant (Ubrelvy®). Several CGRP inhibitors are indicated for migraine prevention, including oral atogepant (Qulipta™), rimegepant ODT, and the injectable monoclonal antibodies eptinezumab-jjmr (Vyepti®), erenumab (Aimovig®), fremanezumab (Ajovy®), and galcanezumab (Emgality®). If approved, zavegepant will be the first intranasal CGRP inhibitor formulation for the acute treatment of migraine attacks. It will provide another option for migraine relief. In clinical trials, onset of effect was seen as early as 15 minutes and lasted for up to 48 hours in some patients. Other treatment options that bypass the GI tract are intranasal triptans (Imitrex®, Onzetral® Xsail®, Tosymra®, Zomig®), ODT rimegepant (Nurtec ODT), ODT triptans (Maxalt MLT®, Zomig ZMT®), and injectable triptans (Imitrex, Zembrace® SymTouch®). An oral formulation of zavegepant is also in phase 3 trials for migraine prevention.
FDA APPROVAL TIMELINE January to March 2023
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$0
$39
$129
$195
$242
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Biosimilar Overview CLINICAL OVERVIEW
Biosimilars are very different from generic drugs in that they are not exact duplicates of their reference biologic product. The FDA approval process for biosimilars is designed to ensure that the biosimilar product is highly similar to the reference product without having any meaningful clinical differences. Moreover, an interchangeable biological product is a biosimilar that is expected to produce the same clinical result as the reference product in any given patient. Switching or alternating between the reference and interchangeable products should have been evaluated and should not negatively impact the safety and efficacy of therapy. Many controversies have surrounded biosimilars, and regulatory and litigation hurdles remain. The FDA has issued final and draft guidances. Select FDA biosimilar guidances are noted here. In January 2017, the agency issued final guidance on the nonproprietary naming of biologic products, which also applies to biosimilars. The biological products must bear a core name followed by a distinguishing 4-letter, lowercase, hyphenated suffix that is devoid of meaning. The international nonproprietary name (INN) impacts interchangeability as it affects pharmacists’ ability to substitute an interchangeable biosimilar for the reference product. The FDA withdrew the September 2017 draft industry guidance on determining similarity of a proposed biosimilar product to its reference product to allow for further consideration of the most current and relevant scientific methods in evaluating analytical data. The agency focuses on providing flexibility for the efficient development of biosimilars while maintaining high scientific standards. In July 2018, the FDA finalized its guidance on labeling biosimilars. The guidance pertains to prescribing information (PI) but does not contain specific recommendations on interchangeability in the labeling. The labeling guidance provides recommendations on how to include, identify, and differentiate the biosimilar and the reference product in various sections of the PI. The basic premise remains that the originator product’s safety and effectiveness can be relied upon for HCPs to make prescribing decisions; therefore, a biosimilar should include relevant data from the originator in its PI. In May 2019, the agency released its final guidance on interchangeability. Most states have enacted biosimilar substitution laws. An interchangeable product may be substituted for the originator at the pharmacy without the involvement of the prescriber. The Purple Book is an FDA database of licensed biological products that lists biosimilar and interchangeable products. The FDA has approved 2 biosimilars for interchangeability to their reference product: insulin glargine-yfgn (Semglee®) and adalimumab-adbm (Cyltezo®). Biosimilars can receive extrapolation to gain an indication without direct trials of the biosimilar for the eligible indication(s) of the reference products without requiring additional trials. Nevertheless, as each biosimilar comes to market, it will need to be considered individually. The FDA historically regulated insulins as small molecules. However, effective March 23, 2020, drugs such as insulin and growth hormone were deemed biologics and transitioned from the drug pathway to the biologic pathway. Their licensure as biologics allows these agents to be considered in the biosimilar space and promotes competition and access.
PLACE IN THERAPY
The patents of several biologic drugs are set to expire in the next few years, opening the US market for biosimilar entry; however, patent litigation has resulted in significant launch delays of FDA-approved biosimilars. In June 2017, the US Supreme Court issued 2 landmark rulings: (1) allowing a biosimilar manufacturer to provide launch notice of commercial marketing to the originator manufacturer before or after FDA approval of the biosimilar product and (2) eliminating any federal requirement for disclosure, also known as the “patent dance.” Some states, however, mandate disclosure. These decisions may bring biosimilars to the market sooner and potentially create price competition in the marketplace. In July 2018, the FDA unveiled its Biosimilar Action Plan (BAP), a series of 11 steps to encourage biosimilar market competition, some of which were previously announced or underway. The BAP contains 4 key strategies: (1) improve the biosimilar development and approval process; (2) maximize scientific and regulatory clarity for sponsors; (3) provide effective communications for patients, clinicians, and payers; and (4) reduce unfair tactics that may delay market approval and entry. The BAP strives to promote access to biosimilar products and reduce healthcare costs.
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To date, a total of 36 biosimilars have received FDA approval. Of these, only 24 have entered the market. APPROVED BIOSIMILARS Brand Name (Nonproprietary name)
Manufacturer
Approval Date
Zaxio® (filgrastim-sndz)
Novartis/Sandoz
March 2015
Inflectra® (infliximab-dyyb)
Pfizer/Celltrion
April 2016
Erelzi® (etanercept-szzs)
Novartis/Sandoz
August 2016
Amjevita™ (adalimumab-atto)
Amgen
September 2016
Renflexis® (infliximab-abda)
Samsung Bioepis/ Merck
May 2017
Cyltezo (adalimumab-adbm)
Boehringer Ingelheim
August 2017
Mvasi® (bevacizumab-awwb)
Amgen
September 2017
Ixifi™ (infliximab-qbtx)†
Pfizer
December 2017
Ogivri® (trastuzumab-dkst)
Viatris
December 2017
Retacrit® (epoetin alfa-epbx)
Pfizer/Hospira
May 2018
Fulphila® (pegfilgrastim-jmdb)
Viatris
June 2018
Nivestym® (filgrastim-aafi)
Pfizer
July 2018
Hyrimoz™ (adalimumab-adaz)
Novartis/Sandoz
October 2018
Udenyca® (pegfilgrastim-cbqv)
Coherus
November 2018
Truxima® (rituximab-abbs)
Celltrion/Teva
November 2018
Herzuma® (trastuzumab-pkrb)
Celltrion/Teva
December 2018
Ontruzant® (trastuzumab-dttb)
Samsung Bioepis/ Merck
January 2019
Trazimera™ (trastuzumab-qyyp)
Pfizer
March 2019
Eticovo™ (etanercept-ykro)
Samsung Bioepis/ Merck
April 2019
Kanjinti™ (trastuzumab-anns)
Amgen
June 2019
Zirabev® (bevacizumab-bvzr)
Pfizer
June 2019
Hadlima™ (adalimumab-bwwd)
Samsung Bioepis/ Merck
July 2019
Ruxience® (rituximab-pvvr)
Pfizer
July 2019
Abrilada™ (adalimumab-afzb)
Pfizer
November 2019
Ziextenzo® (pegfilgrastim-bmez)
Novartis/Sandoz
November 2019
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Interchangeable -
Commercially Available
Originator (Manufacturer) Neupogen® (Amgen) Remicade® (Janssen)
-
-
Enbrel® (Amgen)
-
-
Humira (Abbvie)
-
-
-
-
-
-
-
-
Remicade (Janssen) Humira (Abbvie) Avastin (Genentech) Remicade (Janssen) Herceptin® (Genentech) Epogen® (Amgen) Procrit® (Janssen) Neulasta® (Amgen) Neupogen (Amgen) Humira (Abbvie) Neulasta (Amgen) Rituxan® (Genentech) Herceptin (Genentech) Herceptin (Genentech) Herceptin (Genentech) Enbrel (Amgen) Herceptin (Genentech) Avastin (Genentech) Humira (Abbvie)
-
-
-
-
-
Humira (Abbvie)
-
Neulasta (Amgen)
Rituxan (Genentech)
APPROVED BIOSIMILARS continued APPROVED BIOSIMILARS Brand Name (Nonproprietary name)
Manufacturer
Approval Date
Avsola® (infliximab-axxq)
Amgen
December 2019
Nyvepria™ (pegfiltrastim-apgf)
Pfizer
June 2020
Semglee (insulin glargine-yfgn)
Viatris
July 2021
Hulio® (adalimumab-fkjp)
Viatris
July 2020
Riabni™ (rituximab-arrx)
Amgen
December 2020
Byooviz (ranibizumab-nuna)
Biogen/Samsung Bioepis
September 2021
Rezvoglar™ (insulin glargine-aglr)
Eli Lilly
December 2021
Yusimry™ (adalimumab-aqvh)
Coherus
December 2021
Releuko® (filgrastim-ayow)
Amneal
March 2022
Alymsys® (bevacizumab-maly)
Amneal
April 2022
Fylnetra® (pegfilgrastim-pbbk)
Amneal
May 2022
Interchangeable
Commercially Available
-
-
-
-
Originator (Manufacturer) Remicade (Janssen) Neulasta (Amgen) Lantus® (Sanofi-Aventis) Humira (Abbvie) Rituxan (Genentech) Lucentis® (Genentech)
-
-
Lantus (Sanofi)
-
-
Humira (Abbvie)
-
-
Neupogen (Amgen) Avastin (Genentech) Neulasta (Amgen)
† Pfizer already has Inflectra on the market and has not announced plans to launch Ixifi.
Also available are Eli Lilly’s Basaglar® insulin glargine, a follow-on to Sanofi’s Lantus, and Sanofi’s Admelog® insulin lispro approved as a follow-on to Eli Lilly’s Humalog®. Specialty medications, which include biologics, continue to grow and constitute a large part of drug spend. In the US, it is estimated that biosimilars will cost approximately 15% to 35% less than the originator product, although price dynamics vary. Further, the potential cost savings can vary based on the market segment where brand contracts can play a role. A host of factors will contribute to market acceptability and the potential success of biosimilars. Payers, pharmacies, prescribers, and patients each play an important role in market adoption of biosimilars. Biosimilars are paving the way for increased access to important biologic therapies that may increase survival and/ or QOL for many patients with difficult-to-treat diseases while also reducing costs.
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BIOSIMILAR OVERVIEW continued
IMMUNOLOGY
adalimumab SC Fresenius is seeking approval for its investigational biosimilar to Abbvie’s Humira 50 mg/mL; Alvotech, Celltrion, Samsung Bioepis/Organon, and Sandoz are seeking approval for their investigational biosimilars to Abbvie’s citratefree, high-concentration (100 mg/mL) Humira. Abbvie’s Humira is a tumor necrosis factor alpha (TNF-α) blocker indicated for the treatment of autoimmune disorders, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), plaque psoriasis (PSO), psoriatic arthritis (PsA), Crohn’s disease (CD) in adults and children, ulcerative colitis (UC), hidradenitis suppurativa (HS), and non-infectious uveitis. Pfizer is seeking interchangeability of FDA-approved adalimumab-afzb (Abrilada) 50 mg/mL. Samsung Bioepis/ Organon and Sandoz are seeking approval for 100 mg/mL concentrations of FDA-approved adalimumab-bwwd (Hadlima) and adalimumab-adaz (Hyrimoz), respectively.
FDA APPROVAL TIMELINE
50 mg/mL • Fresenius (MSB11022) – October to December 2022 • Pfizer (Abrilada) – October to December 2022 for interchangeability 100 mg/mL • Alvotech (AVT-02) – December 2022 for initial approval and interchangeability • Celltrion (Yuflyma) – August 2022 • Samsung Bioepis/Organon (Hadlima) – August 2022 • Sandoz (Hyrimoz) – March to April 2022
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$18,552
$10,899
$7,231
$5,527
$4,423
The forecast is a projection of total US sales per year for the branded originator product.
OPHTHALMOLOGY
aflibercept intravitreal Viatris/Janssen Viatris/Janssen is seeking approval of their investigational biosimilar (M710) to Regeneron’s Eylea®, a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
FDA APPROVAL TIMELINE October 2022
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$6,221
$6,303
$6,009
$5,338
$4,618
The forecast is a projection of total US sales per year for the branded originator product.
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BIOSIMILAR OVERVIEW continued
ONCOLOGY
bevacizumab IV Bio-Thera Solutions/Novartis, Celltrion, Centus/AstraZeneca, Samsung Bioepis/Organon, and Viatris/Biocon are seeking approval for their investigational biosimilars to Genentech’s Avastin, a vascular endothelial growth factor (VEGF)-specific angiogenesis inhibitor indicated for the treatment of metastatic colorectal cancer, nonsquamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma (RCC), and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
FDA APPROVAL TIMELINE • • • • •
Bio-Thera Solutions/Novartis (BAT1706) – Pending Celltrion (CT-P16) – October 2022 Centus/AstraZeneca (FKB238) – Pending Samsung Bioepis/Organon (Aybintio) – Pending Viatris/Biocon (Bmab-100) – Pending
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$598
$477
$405
$362
$325
The forecast is a projection of total US sales per year for the branded originator product.
BLOOD MODIFIER
filgrastim IV, SC Apotex Apotex is seeking approval of their investigational biosimilar (Grastofil) to Amgen’s Neupogen, a leukocyte growth factor indicated for use in patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs; following induction or consolidation chemotherapy for acute myeloid leukemia (AML); with nonmyeloid malignancies in patients who are undergoing myeloablative chemotherapy followed by bone marrow transplantation; to mobilize autologous hematopoietic progenitor cells for collection by leukapheresis; with symptomatic congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and in patients who are acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome [HSARS]).
FDA APPROVAL TIMELINE Pending
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$57
$50
$45
$40
$37
The forecast is a projection of total US sales per year for the branded originator product.
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BIOSIMILAR OVERVIEW continued
BLOOD MODIFIER
pegfilgrastim SC Apotex, Lupin, and Merck/Fresenius are seeking approval for their investigational biosimilars to Amgen’s Neulasta, a leukocyte growth factor indicated for use in patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs and in patients acutely exposed to myelosuppressive doses of radiation (HSARS).
FDA APPROVAL TIMELINE
• Apotex (Lapelga) – Pending • Lupin (Lupifil-P) – Pending • Merck/Fresenius (MSB-11455) – Pending
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$863
$643
$553
$486
$442
The forecast is a projection of total US sales per year for the branded originator product.
IMMUNOLOGY
ranibizumab intravitreal Coherus Coherus is seeking approval for their investigational biosimilar (FYB201) to Genentech’s Lucentis, a vascular endothelial growth factor (VEGF) inhibitor indicated to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy, and myopic choroidal neovascularization (mCNV).
FDA APPROVAL TIMELINE August 2, 2022
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$1,235
$909
$668
$516
$431
The forecast is a projection of total US sales per year for the branded originator product.
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BIOSIMILAR OVERVIEW continued
ONCOLOGY
trastuzumab IV Novartis and Tanvex are seeking approval for their investigational biosimilars to Genentech’s Herceptin, a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA APPROVAL TIMELINE Novartis December 20, 2022 Tanvex (TX05) August 2022
FINANCIAL FORECAST (reported in millions) Year
2022
2023
2024
2025
2026
Projected Total US Sales
$418
$356
$315
$284
$258
The forecast is a projection of total US sales per year for the branded originator product.
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Keep on Your RADAR Notable agents that are further from approval have been identified in this unique watch list. These are products with the potential for significant clinical and financial impact. Their development status is being tracked on the MRx Pipeline radar. These pipeline products, their respective class or proposed indication, as well as an estimated financial forecast for the year 2026, are displayed. The financials are projected total annual US sales, reported in millions. zuranolone
adagrasib
$678
$881
Behavioral health
tiragolumab Oncology
$785
Oncology
dextromethorphan/ bupropion Behavioral health
$812
tabelecleucel
donanemab
Oncology
Neurology
$316
$1,887
resmetirom
exa-cel (CTX001)
Cardiovascular
Hematology/Gene therapy
$548
$949
nirsevimab
fidanacogene elaparvovec
Infectious disease
Hematology/Gene therapy
$411
$267
mirikizumab
gantenerumab
$687
$1,836
Neurology
Immunology
lenadogene nolparvovec (GS-010)
Ophthalmology/Gene therapy
$59
giroctocogene fitelparvovec Gene therapy/Hematology
$205
pecialty drug names appear in S magenta throughout the publication.
Pipeline DRUG LIST The pipeline drug list is an aerial outline of drugs with anticipated FDA approval through 2023. It is not intended to be a comprehensive inventory of all drugs in the pipeline; emphasis is placed on drugs in high-impact categories. Investigational drugs with a Complete Response Letter (CRL) and those that have been withdrawn from development are also noted. APPLICATION APPLICATION SUBMITTED SUBMITTED TO THE FDA
PHASE3 3 IN PHASE TRIALS TRIALS
68%
68%
32%
32%
38%
33%
21%
Specialty
26%
13%
17%
10 %
Traditional
Orphan Drug
Priority Review
Breakthrough Therapy
Biosimilar
pecialty drug names appear in S magenta throughout the publication.
PIPELINE DRUG LIST Specialty drug names appear in magenta throughout the publication. NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
Submitted (New Drugs) ravulizumab-cwvz (Ultomiris® SC)
AstraZeneca
Hemolytic uremic syndrome (atypical); PNH
SC
Submitted – BLA; Orphan Drug
July 2022
spesolimab
Boehringer Ingelheim
Generalized pustular psoriasis (GPP)
IV, SC
Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review
July 2022
bulevirtide
Gilead
Hepatitis D infection treatment (in patients with compensated liver disease)
SC
Submitted – BLA; Breakthrough Therapy; Orphan Drug
Jul–Nov 2022
infliximab SC
Celltrion
IBS
SC
Submitted – BLA
Jul–Dec 2022
roflumilast cream
Arcutis/AstraZeneca
PSO (mild–severe)
Topical
Submitted – NDA
07/29/2022
adalimumab 100 mg/mL (biosimilar to Abbvie’s Humira)
Celltrion
RA; AS; PSO; PsA; JIA; CD; UC
SC
Submitted – BLA
August 2022
narsoplimab
Omeros
HSCT-associated thrombotic microangiopathy
IV, SC
Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review
August 2022
trastuzumab (biosimilar to Genentech’s Herceptin)
Tanvex
Breast cancer; Gastric/ gastroesophageal cancer
IV
Submitted – BLA
August 2022
teclistamab
Janssen
Multiple myeloma (R/R)
SC
Submitted – BLA; Breakthrough Therapy; Orphan Drug
Aug–Dec 2022
ranibizumab (biosimilar to Genentech’s Lucentis)
Coherus
Wet AMD; Macular edema following RVO; Myopic choroidal neovascularization (mCNV)
Intravitreal
Submitted – BLA
08/02/2022
betibeglogene autotemcel (Zynteglo)
Bluebird Bio
β-thalassemia (transfusion-dependent)
IV
Submitted – BLA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review
08/19/2022
miglustat
Amicus
Pompe disease (in combination with cipaglucosidase alfa)
Oral
Submitted – NDA
08/29/2022
microbiota suspension
Ferring
Clostridioides difficile infection (recurrent)
Rectal
Submitted – BLA; Breakthrough Therapy; Fast Track; Orphan Drug
Sep–Nov 2022
deucravacitinib
Bristol-Myers Squibb
PSO (moderate–severe)
Oral
Submitted – NDA
09/09/2022
eflapegrastim
Spectrum
Chemotherapy inducedneutropenia
SC
Submitted – BLA
09/09/2022
linzagolix
Obseva
Uterine fibroid-related Oral heavy menstrual bleeding
Submitted – NDA
09/13/2022
dasatinib
Xspray
CML
Oral
Submitted – 505(b)(2) NDA; Orphan Drug
09/16/2022
elivaldogene autotemcel (Lenti-D)
Bluebird Bio
Cerebral adrenoleukodystrophy (pediatrics)
IV
Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review; Rare Pediatrics Disease
09/16/2022
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PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
sodium thiosulfate
Fennec
Chemotherapy-induced ototoxicity prevention
IV
Submitted – NDA; Breakthrough Therapy; Fast Track; Orphan Drug
09/23/2022
taurolidine/citrate/heparin
Cormedix
Reduction of catheterrelated bloodstream infections (CRBSIs) related to chronic hemodialysis
IV
Submitted – NDA; Fast Track; QIDP
09/28/2022
sodium phenylbutyrate/ tauroursodiol
Amylyx
ALS
Oral
Submitted – NDA; Orphan 09/29/2022 Drug; Priority Review
futibatinib
Otsuka
Cholangiocarcinoma (locally advanced or metastatic, prior treatment, FGFR2 gene rearrangements)
Oral
Submitted – NDA; Breakthrough Therapy; Orphan Drug; Priority Review
09/30/2022
aflibercept (biosimilar to Regeneron’s Eylea)
Viatris/Janssen
DME; Diabetic retinopathy; Macular edema following RVO; Wet AMD
Intravitreal
Submitted – BLA
October 2022
bevacizumab (biosimilar to Genentech’s Avastin)
Celltrion
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
October 2022
treosulfan
Medac
Allogenic-HSCT conditioning
IV
Submitted – NDA; Orphan October 2022 Drug
adalimumab 50 mg/mL (biosimilar to Abbvie’s Humira)
Fresenius
RA; AS; PSO; PsA; JIA; CD; UC
SC
Submitted – BLA
Oct–Dec 2022
tremelimumab
AstraZeneca
HCC (as single priming dose for durvalumab)
IV
Submitted – BLA; Orphan Drug; Priority Review
Oct–Dec 2022
olipudase alfa
Sanofi
Niemann-Pick disease (acid sphingomyelinase deficiency)
IV
Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review
10/03/2022
apomorphine infusion pump
Supernus
Parkinson’s disease
SC
Submitted – NDA
10/07/2022
furosemide
scPharmaceuticals
Decompensated heart failure
SC
Submitted – 505(b)(2) NDA
10/08/2022
cipaglucosidase alfa
Amicus
Pompe disease (in combination with oral miglustat)
IV
Submitted – BLA; Breakthrough Therapy; Orphan Drug
10/29/2022
etranacogene dezaparvovec
CSL Behring
Hemophilia B
IV
Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review
November 2022
omidenepag isopropyl
Santen
Glaucoma/ocular hypertension
Ophthalmic
Submitted – NDA
11/04/2022
sparsentan
Travere/BristolMyers Squibb
Immunoglobulin A nephropathy (Berger’s disease)
Oral
Submitted – NDA; seeking Accelerated Approval; Orphan Drug; Priority Review
11/17/2022
teplizumab
Provention Bio
T1DM (delay/prevention)
IV
Submitted – BLA; Breakthrough Therapy; Orphan Drug
11/17/2022
23 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
poziotinib
Spectrum
NSCLC (locally advanced/ metastatic; HER2 exon 20 insertion mutations)
Oral
Submitted – NDA; Fast Track
mirvetuximab soravtansine
Immunogen
Ovarian cancer (folate receptor alpha [FRα]high platinum-resistant, 1-3 prior systemic treatments)
IV
Submitted – BLA; seeking 11/28/2022 Accelerated Approval; Fast Track; Orphan Drug; Priority Review
omaveloxolone
Reata/Abbvie
Friedreich’s ataxia
Oral
Submitted – NDA; Fast Track; Orphan Drug; Priority Review; Rare Pediatric Disease
11/30/2022
omburtamab
Y-mAbs
Brain cancer (CNS/ leptomeningeal metastasis from neuroblastoma)
Intracerebroventricular
Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review
11/30/2022
adalimumab 100 mg/mL (biosimilar to Abbvie’s Humira)
Alvotech
RA; AS; PSO; PsA; JIA; CD; UC
SC
Submitted – BLA; seeking biosimilar interchangeability
December 2022
terlipressin
Mallinckrodt
Hepatorenal syndrome
IV
Submitted – NDA; Fast Track; Orphan Drug
December 2022
adagrasib
Mirati
NSCLC (KRAS G12C mutation, ≥ 2nd-line)
Oral
Submitted – NDA; seeking Accelerated Approval; Breakthrough Therapy; RTOR
12/14/2022
trastuzumab (biosimilar to Genentech’s Herceptin)
Novartis
Breast cancer; Gastric/ gastroesophageal cancer
IV
Submitted – BLA
12/20/2022
toripalimab
Coherus
Nasopharyngeal cancer (advanced recurrent/ metastatic, 1st-line with chemotherapy, monotherapy for ≥ 2ndline)
IV
Submitted – BLA; Breakthrough Therapy; Orphan Drug
12/23/2022
ublituximab
TG Therapeutics
MS (relapsing)
IV
Submitted – BLA
12/28/2022
mosunetuzumab
Genentech
Follicular lymphoma (3rdline)
IV, SC
Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review
12/29/2022
palovarotene
Ipsen
Fibrodysplasia ossificans progressiva
Oral
Submitted – NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review
12/29/2022
sodium phenylbutyrate
Acer
Urea cycle disorders
Oral
Submitted – 505(b)(2) NDA
January 2023
budesonide/albuterol
AstraZeneca
Asthma
Inhaled
Submitted – NDA
Jan–Feb 2023
zavegepant
Biohaven/BristolMyers Squibb
Migraine treatment
Intranasal
Submitted – NDA
Jan–Mar 2023
elacestrant
Menarini
Breast cancer (ER+/HER2-, Oral advanced or metastatic)
Submitted – NDA; Fast Track
Jan–Jun 2023
momelotinib
Sierra Oncology/ Gilead
Myelofibrosis
Submitted – NDA; Fast Track; Orphan Drug
Jan–Jun 2023
24 | MAGELLANRX.COM
Oral
11/24/2022
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
lecanemab
Eisai/Biogen
Alzheimer’s disease (early)
IV
Submitted – BLA; seeking 01/06/2023 Accelerated Approval; Breakthrough Therapy; Fast Track; Priority Review
daprodustat
GlaxoSmithKline
Anemia of CKD (dialysisdependent and -independent)
Oral
Submitted – NDA
02/01/2023
omecamtiv mecarbil
Cytokinetics
Heart failure with reduced ejection fraction (HFrEF)
Oral
Submitted – NDA; Fast Track
02/28/2023
tixagevimab/cilgavimab (Evusheld™)
AstraZeneca
COVID-19 treatment
IM, IV
Submitted – BLA
March 2023
trofinetide
Acadia
Rett syndrome (ages ≥ 2 years)
Oral
Submitted – NDA; Fast Track; Orphan Drug
3/17/2023
anthrax vaccine, adsorbed
Emergent
Anthrax infection (postexposure prophylaxis)
IM
Submitted – BLA; Fast Track
April 2023
mirikizumab
Eli Lilly
UC
IV, SC
Submitted – BLA
04/28/2023
(vic-)trastuzumab duocarmazine
Byondis
Breast cancer (HER2+, unresectable locally advanced or metastatic)
IV
Submitted – BLA; Fast Track
05/12/2023
foscarbidopa/foslevodopa
Abbvie
Parkinson’s disease motor SC fluctuations
Submitted – NDA
05/20/2023
nogapendekin alfa inbakicept
Immunitybio
Bladder cancer (BCG-unresponsive, non-muscle invasive carcinoma in situ, in combination with BCG)
Intravesical
Submitted – BLA; Breakthrough Therapy; Fast Track
05/23/2023
sotagliflozin
Lexicon
Heart failure in patients with T2DM
Oral
Submitted – NDA
05/31/2023
efanesoctocog alfa
Sanofi
Hemophilia A
IV
Submitted – BLA; Breakthrough Therapy; Fast Track; Orphan Drug
June 2023
landiolol
Eagle
Supraventricular tachycardia (short-term reduction of ventricular rate)
IV
Submitted – NDA
06/01/2023
beremagene geperpavec
Krystal
Epidermolysis bullosa
Topical
Submitted – BLA; Fast 06/23/2023 Track; Orphan Drug; RMAT
fezolinetant
Astellas
Menopause vasomotor symptoms
Oral
Submitted – NDA
06/23/2023
nirmatrelvir/ritonavir (Paxlovid)
Pfizer
COVID-19 treatment (high-risk patients)
Oral
Submitted – NDA
06/30/2023
bevacizumab (biosimilar to Genentech’s Avastin)
Bio-Thera Solutions/ Novartis
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
Pending
bevacizumab (biosimilar to Genentech’s Avastin)
Centus/AstraZeneca
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
Pending
bevacizumab (biosimilar to Genentech’s Avastin)
Samsung Bioepis/ Organon
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
Pending
bevacizumab (biosimilar to Genentech’s Avastin)
Viatris/Biocon
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
Pending
25 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
casirivimab/imdevimab (Regen-Cov)
Regeneron
COVID-19 treatment (non-hospitalized patients); COVID-19 postexposure prophylaxis
IM, IV, SC
Submitted – BLA; Priority Review
Pending
dextromethorphan/ bupropion
Axsome
MDD
Oral
Submitted – 505(b) (2) NDA; Breakthrough Therapy; Fast Track; Priority Review
Pending
diazepam buccal film
Aquestive
Seizure clusters
Oral transmucosal
Submitted – 505(b)(2) NDA; Fast Track; Orphan Drug
Pending
filgrastim (biosimilar to Amgen’s Neupogen)
Apotex
Neutropenia/leukopenia
IV, SC
Submitted – BLA
Pending
lenacapavir
Gilead
HIV-1 infection (heavily treatment-experienced)
Oral, SC
Submitted – NDA; Breakthrough Therapy
Pending
pegfilgrastim (biosimilar to Amgen’s Neulasta)
Apotex
Neutropenia/leukopenia
SC
Submitted – BLA
Pending
pegfilgrastim (biosimilar to Amgen’s Neulasta)
Lupin
Neutropenia/leukopenia
SC
Submitted – BLA
Pending
pegfilgrastim (biosimilar to Amgen’s Neulasta)
Merck/Fresenius
Neutropenia/leukopenia
SC
Submitted – BLA
Pending
sabizabulin
Veru
COVID-19 treatment
Oral
Submitted – EUA; Fast Track
Pending
sodium oxybate (oncenightly)
Avadel
Narcolepsy-related excessive daytime sleepiness and cataplexy
Oral
Submitted – 505(b)(2) NDA; Orphan Drug
Pending
tislelizumab
Beigene/Novartis
Esophageal squamous cell carcinoma (unresectable, recurrent, locally advanced/ metastatic, after prior systemic therapy)
IV
Submitted – BLA; Orphan Drug
Pending
Submitted (Supplementals) durvalumab (Imfinzi )
AstraZeneca
Biliary tract cancer (in combination with chemotherapy)
IV
Submitted – sBLA; Orphan Drug; Priority Review
Jul–Sep 2022
fam-trastuzumab deruxtecan-nxki (Enhertu®)
Daiichi Sankyo/ AstraZeneca
NSCLC (unresectable or metastatic, HER2+, ≥ 2nd-line)
IV
Submitted – sBLA; Breakthrough Therapy; Priority Review
Jul–Sep 2022
tocilizumab (Actemra®)
Genentech
COVID-19 treatment (hospitalized adults on systemic corticosteroids and require assisted ventilation)
IV
Submitted – sBLA; Priority Review
Jul–Dec 2022
adalimumab-bwwd 100 mg/mL (Hadlima) (biosimilar to Abbvie’s Humira)
Samsung Bioepis/ Organon
RA; AS; PSO; PsA; JIA; CD; UC
SC
Submitted – sBLA
August 2022
pimavanserin (Nuplazid®)
Acadia
Alzheimer’s diseaseOral related hallucinations and delusions
Submitted – sNDA; Breakthrough Therapy
08/04/2022
relugolix/estradiol/ norethindrone (Myfembree®)
Myovant
Endometriosis
Oral
Submitted – sNDA
08/06/2022
ustekinumab (Stelara®)
Janssen
PsA (ages ≥ 5 years)
SC
Submitted – sBLA
08/08/2022
®
26 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
aprepitant (Cinvanti®)
Heron
Postoperative nausea and vomiting prophylaxis
IV
Submitted – 505(b)(2) sNDA
09/18/2022
dupilumab (Dupixent®)
Sanofi/Regeneron
Prurigo nodularis
SC
Submitted – sBLA; Priority Review
09/30/2022
adalimumab-afzb 50 mg/mL (Abrilada) (biosimilar to Abbvie’s Humira)
Pfizer
RA; AS; PSO; PsA; JIA; CD; UC
SC
Submitted – PAS BLA for biosimilar interchangeability
Oct–Dec 2022
ibalizumab-uiyk (Trogarzo®) Theratechnologies IV push
HIV-1 treatment
IV
Submitted – sBLA; Breakthrough Therapy; Fast Track; Orphan Drug
10/03/2022
lumasiran (Oxlumo®)
Alnylam
Primary hyperoxaluria type 1 (advanced)
SC
Submitted – sNDA; Breakthrough Therapy; Orphan Drug
10/06/2022
darolutamide (Nubeqa®)
Bayer
Prostate cancer (metastatic, hormonesensitive, in combination with docetaxel)
Oral
Submitted – sNDA; Fast Track; Priority Review
11/03/2022
upadacitinib (Rinvoq™)
Abbvie
Axial spondyloarthritis (non-radiographic)
Oral
Submitted – sNDA
11/07/2022
pegcetacoplan (Empaveli®)
Apellis
Geographic atrophy (secondary to AMD)
Intravitreal
Submitted – sNDA; Fast Track; Priority Review
11/26/2022
asparaginase erwina Jazz chysanthemi (recombinant)rywn (Rylaze™ IM)
AML and Lymphoblastic lymphoma (3 times a week IM dosing, with chemotherapy, ages ≥ 1 month, E. coliderived asparaginase hypersensitivity)
IM
Submitted – sBLA; Fast Track; Orphan Drug; RTOR
12/02/2022
cariprazine (Vraylar®)
Abbvie
MDD (adjunct)
Oral
Submitted – sNDA
12/22/2022
abaloparatide (Tymlos®)
Radius
Osteoporosis (men, highrisk for fracture)
SC
Submitted – sNDA
12/23/2022
ibrutinib (Imbruvica®)
Abbvie/Janssen
GVHD treatment (ages ≥ 1 years, ≥ 2nd-line)
Oral
Submitted – sNDA; Breakthrough Therapy; Orphan Drug
12/28/2022
lumacaftor/ivacaftor (Orkambi®)
Vertex
Cystic fibrosis (ages 12 to 23 months)
Oral
Submitted – sNDA; Breakthrough Therapy; Orphan Drug
January 2023
vonoprazan fumarate (Takecab®)
Phathom
Erosive esophagitis; Heartburn relief
Oral
Submitted – sNDA
01/11/2023
zanubrutinib (Brukinsa®)
Beigene
CLL/SLL
Oral
Submitted – sNDA; Orphan Drug
01/20/2023
pembrolizumab (Keytruda®)
Merck
NSCLC (post surgical resection; stage 1B, II, or IIIA)
IV
Submitted – sBLA
01/29/2023
relugolix/estradiol/ norethindrone (Myfembree)
Myovant
Uterine fibroids (premenopausal women)
Oral
Submitted – sNDA
01/29/2023
asparaginase erwina Jazz chysanthemi (recombinant)rywn (Rylaze IV)
ALL
IV
Submitted – sBLA; Fast Track; Orphan Drug; RTOR
February 2023
aflibercept (Eylea)
Diabetic retinopathy (16-week maintenance regimen)
Intravitreal
Submitted – sBLA
2/28/2023
27 | MAGELLANRX.COM
Regeneron
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
amifampridine phosphate (Firdapse®)
Catalyst
Lambert-Eaton myasthenic syndrome (pediatric)
Oral
Submitted – sNDA; Breakthrough Therapy; Orphan Drug
March 2023
adalimumab-adaz 100 mg/ mL (Hyrimoz) (biosimilar to Abbvie’s Humira)
Sandoz
RA; AS; PSO; PsA; JIA; CD; UC
SC
Submitted – sBLA
March–April 2023
ibrexafungerp (Brexafemme®)
Scynexis
Recurrent vulvovaginal candidiasis prevention
Oral
Submitted – sNDA; Fast Track; Orphan Drug; QIDP
April 2023
durvalumab (Imfinzi)
AstraZeneca
HCC (unresectable)
IV
Submitted – sBLA; Orphan Drug
04/30/2023
baricitinib (Olumiant®)
Eli Lilly
Atopic dermatitis (moderate–severe)
Oral
Submitted – sNDA
Pending
norgestrel (Opill®)
Perrigo
Contraception
Oral
Submitted – Rx-to-OTC
Pending
Phase 3 (New Drugs) AAV-RPGR gene therapy
Janssen
Retinitis pigmentosa (X-linked)
Intraoccular
Phase 3 – BLA; Fast Track; Orphan Drug
TBD
abaloparatide-TD
Radius
Osteoporosis/osteopenia
Transdermal
Phase 3 – NDA
TBD
abelacimab
Anthos
Venous thromboembolism
IV, SC
Phase 3 – BLA; Fast Track
TBD
acoramidis
Bridgebio/ AstraZeneca
Transthyretin amyloid cardiomyopathy (ATTRCM)
Oral
Phase 3 – NDA
TBD
adintrevimab
Adagio
COVID-19
IM
Phase 3 – BLA
TBD
aflibercept (biosimilar to Regeneron’s Eylea)
Alvotech
DME; Wet AMD
Intravitreal
Phase 3 – BLA
TBD
aflibercept (biosimilar to Regeneron’s Eylea)
Amgen
DME; Wet-AMD
Intravitreal
Phase 3 – BLA
TBD
aflibercept (biosimilar to Regeneron’s Eylea)
Sam Chun Dang
DME; Wet-AMD
Intravitreal
Phase 3 – BLA
TBD
aflibercept (biosimilar to Regeneron’s Eylea)
Samsung Bioepis/ Biogen
DME; Wet-AMD
Intravitreal
Phase 3 – BLA
TBD
aflibercept (biosimilar to Regeneron’s Eylea)
Santo/Formycon
DME; Wet-AMD
Intravitreal
Phase 3 – BLA
TBD
aloradine
Vistagen
Social anxiety disorder
Intranasal
Phase 3 – NDA; Fast Track
TBD
amcenestrant
Sanofi
Breast cancer
Oral
Phase 3 – NDA
TBD
amubarvimab + romlusevimab
Brii
COVID-19
IV
Phase 3 – BLA
TBD
anti-BDCA2 antibody (BIIB059)
Biogen
SLE
SC
Phase 3 – BLA
TBD
anti-betv1 monoclonal antibodies (REGN-57135714-5715)
Regeneron
Birch allergy
SC
Phase 3 – BLA
TBD
apolipoprotein A-I (human)
CSL
Atherosclerosis
IV
Phase 3 – BLA
TBD
arfolitixorin hemisulfate
Isofol
CRC
IV
Phase 3 – NDA; Fast Track
TBD
arimoclomol
Orphazyme
Niemann-Pick disease
Oral
Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Rare Pediatric Disease
TBD
ataluren
PTC
DMD
Oral
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
28 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells
CRISPR Therapeutics
SCD; Thalassemia
IV
Phase 3 – BLA; Fast Track; Orphan Drug; RMAT
TBD
balstilimab
Agenus
Cervical cancer (R/R, in combination with zalifrelimab)
IV
Phase 3 – BLA; Fast Track
TBD
bamlanivimab
Eli Lilly
COVID-19
IV
Phase 3 – BLA
TBD
bentracimab
Phasebio/ AstraZeneca
Ticagrelor (Brilinta ) reversal
IV
Phase 3 – BLA; Breakthrough Therapy
TBD
beroctocog alfa
Green Cross
Hemophilia A
IV
Phase 3 – BLA
TBD
betibeglogene autotemcel (Zynteglo)
Bluebird Bio
SCD
IV
Phase 3 – BLA; Fast Track; Orphan Drug; RMAT
TBD
bevacizumab-vikg
Outlook
Wet AMD
Intravitreal
Phase 3 – BLA
TBD
bimekizumab
UCB
Axial spondyloarthritis; Hidradenitis suppurativa; PsA
SC
Phase 3 – BLA
TBD
bis-choline tetrathiomolybdate
AstraZeneca
Wilson’s disease
Oral
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
BPR277
Lifemax/Novartis
Congenital ichthyosis
Topical
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
brensocatib
Insmed/AstraZeneca
Bronchiectasis
Oral
Phase 3 – NDA; Breakthrough Therapy
TBD
cannabidiol gel, transdermal
Zynerba
Fragile X syndrome
Topical
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
capsaicin
Centrexion
Osteoarthritis pain (knee)
Intraarticular
Phase 3 – NDA; Fast Track
TBD
ceftobiprole medocaril
Basilea
ABSSSI; Bacteremia; CAP; HAP
IV
Phase 3 – NDA; Fast Track; QIDP
TBD
ceftriaxone wearable micropump
scPharmaceuticals
Gram+/Gram- infection
SC
Phase 3 – NDA
TBD
CM-AT (pancreatic enzyme)
Curemark
Autism spectrum disorders
Oral
Phase 3 – BLA; Fast Track
TBD
cobitolimod
Index/Merck
UC
Rectal
Phase 3 – NDA; Orphan Drug
TBD
concizumab
Novo Nordisk
Hemophilia A and B
SC
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug
TBD
copper histidine
Zydus Cadila
Menkes disease
SC
Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug
TBD
cosibelimab
Fortress
Cutaneous squamous cell carcinoma (metastatic)
IV
Phase 3 – BLA
TBD
COVID-19 vaccine (C19VAZ; formerly AZD1222; ChAdOx1)
AstraZeneca
COVID-19
IM
Phase 3 – BLA
TBD
COVID-19 vaccine (JNJ78436735; formerly Ad26. COV2-S)
Janssen
COVID-19
IM
Phase 3 – BLA
TBD
COVID-19 vaccine (MT2766)
Mitsubishi Tanabe/ GlaxoSmithKline
COVID-19
IM, SC
Phase 3 – BLA
TBD
COVID-19 vaccine (SCB2019)
Clover
COVID-19
SC
Phase 3 – BLA
TBD
29 | MAGELLANRX.COM
®
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
COVID-19 vaccine (SP0253)
Sanofi/ GlaxoSmithKline
COVID-19
IM
Phase 3 – BLA
TBD
crovalimab
Genentech
Hemolytic uremic syndrome; PNH
IV, SC
Phase 3 – BLA; Orphan Drug
TBD
dabocemagene autoficel
Castle Creek
Epidermolysis bullosa
Intradermal
Phase 3 – BLA; Fast Track; Orphan Drug; RMAT
TBD
darvadstrocel
Takeda
CD
IV
Phase 3 – BLA; Orphan Drug
TBD
delandistrogene moxeparvovec
Sarepta/Genentech
DMD
IV
Phase 3 – BLA; Fast Track
TBD
dengue tetravalent vaccine
Takeda
Dengue fever
SC
Phase 3 – BLA; Fast Track
TBD
denosumab (Biosimilar to Amgen’s Prolia®)
Biocon
Osteoporosis/osteopenia
SC
Phase 3 – BLA
TBD
denosumab (Biosimilar to Amgen’s Prolia)
Celltrion
Osteoporosis/osteopenia
SC
Phase 3 – BLA
TBD
denosumab (Biosimilar to Amgen’s Prolia)
Fresenius
Osteoporosis/osteopenia
SC
Phase 3 – BLA
TBD
denosumab (Biosimilar to Amgen’s Prolia)
Gedeon Richter
Osteoporosis/osteopenia
IV
Phase 3 – BLA
TBD
denosumab (Biosimilar to Amgen’s Prolia)
Novartis
Osteoporosis/osteopenia
SC
Phase 3 – BLA
TBD
denosumab (Biosimilar to Amgen’s Prolia)
Teva
Osteoporosis/osteopenia
SC
Phase 3 – BLA
TBD
dersimelagon
Mitsubishi Tanabe
Porphyria
Oral
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
despropyl macitentan
Janssen
Hypertension (resistant)
Oral
Phase 3 – NDA
TBD
difluprednate XR
Sun
Ocular pain/inflammation
Ophthalmic
Phase 3 – NDA
TBD
donanemab
Eli Lilly
Alzheimer’s disease (early)
IV, SC
Phase 3 – BLA; Breakthrough Therapy
TBD
donaperminogene seltoplasmid
Helixmith
Diabetic foot ulcers (chronic non-healing)
IM
Phase 3 – BLA
TBD
doravirine/islatravir
Merck
HIV-1 infection treatment
Oral
Phase 3 – NDA
TBD
dovitinib lactate
Allarity
Breast cancer; RCC (3rdline)
Oral
Phase 3 – NDA
TBD
durlobactam/sulbactam
Entasis
Acinetobacter baumannii infection
IV
Phase 3 – NDA; Fast Track; QIDP
TBD
dust mite immunotherapy
Stallergenes Greer
Allergic rhinitis
SL
Phase 3 – BLA
TBD
EB-101 (gene therapy)
Abeona
Epidermolysis bullosa
Surgical application
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug; RMAT
TBD
eculizumab (biosimilar to Alexion’s Soliris®)
Amgen
PNH
IV
Phase 3 – BLA
TBD
elamipretide
Stealth
Barth syndrome
SC
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
enmetazobactam
Allecra
UTI (complicated)
IV
Phase 3 – NDA; Fast Track; QIDP
TBD
ensifentrine
Verona
COPD
Inhaled
Phase 3 – NDA
TBD
ensovibep
Novartis
COVID-19
IV
Phase 3 – BLA; Fast Track
TBD
epcoritamab
Genmab
DLBCL
SC
Phase 3 – BLA
TBD
epinephrine
Bryn
Anaphylaxis
Intranasal
Phase 3 – NDA; Fast Track
TBD
30 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
episalvan
Amryt
Epidermolysis bullosa
Topical
Phase 3 – NDA; Fast Track; Orphan Drug; Rare Pediatric Disease
TBD
eplontersen
Ionis/AstraZeneca
Transthyretin amyloid polyneuropathy
SC
Phase 3 – NDA; Orphan Drug
TBD
esreboxetine
Axsome/Pfizer
Fibromyalgia
Oral
Phase 3 – NDA
TBD
etanercept (biosimilar to Amgen’s Enbrel)
Lupin
RA; Polyarticular JIA; AS; PSO; PsA
SC
Phase 3 – BLA
TBD
etavopivat
Forma
SCD
Oral
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
etesevimab
Lonza/Eli Lilly
COVID-19
IV
Phase 3 – BLA
TBD
etrasimod
Arena
UC
Oral
Phase 3 – NDA; Orphan Drug
TBD
fasinumab
Regeneron
Osteoarthritis pain (knee)
SC
Phase 3 – BLA
TBD
fexapotide triflutate
Nymox
BPH
Intraprostatic
Phase 3 – NDA
TBD
fidanacogene elaparvovec
Pfizer/Genentech
Hemophilia B
IV
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug
TBD
filgotinib
Gilead
CD; UC
Oral
Phase 3 – NDA
TBD
firibastat
Quantum Genomics
Hypertension (systemic)
Oral
Phase 3 – NDA
TBD
firmacute eubacterial spores
Seres
C. difficile-associated diarrhea
Oral
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug
TBD
fitusiran
Sanofi
Hemophilia A and B
SC
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
follitropin alfa (biosimilar to EMD Serono’s Gonal-F®)
Allergan
Female reproductive disorder
SC
Phase 3 – BLA
TBD
follitropin alfa (biosimilar to EMD Serono’s Gonal-F)
Finox
Female reproductive disorder
SC
Phase 3 – BLA
TBD
FVIII mimetic bi-specific antibody
Novo Nordisk
Hemophilia A
SC
Phase 3 – BLA; Orphan Drug
TBD
gantenerumab
Genentech
Alzheimer’s disease (early)
SC
Phase 3 – BLA; Breakthrough Therapy
TBD
garadacimab
CSL
HAE
SC
Phase 3 – BLA; Orphan Drug
TBD
gavorestat
Applied Therapeutics Galactosemia
Oral
Phase 3 – NDA; Fast Track; Orphan Drug; Rare Pediatric Disease
TBD
GBT601
Global Blood Therapeutics
SCD
Oral
Phase 3 – NDA
TBD
gepotidacin
GlaxoSmithKline
UTI (uncomplicated)
Oral
Phase 3 – NDA; QIDP
TBD
giredestrant
Genentech
Breast cancer
Oral
Phase 3 – NDA; Fast Track
TBD
giroctocogene fitelparvovec
Pfizer
Hemophilia A
IV
Phase 3 – BLA; Fast Track; Orphan Drug; RMAT
TBD
glatiramer acetate depot
Viatris
MS
IM
Phase 3 – 505(b)(2) NDA
TBD
glofitamab
Genentech
DLBCL
IV
Phase 3 – BLA
TBD
gold nanocrystal
Clene
ALS
Oral
Phase 3 – NDA; Orphan Drug
TBD
hypericin
Soligenix
Cutaneous T-cell lymphoma (CTCL)
Topical
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
31 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
idursulfase
Takeda/Sanofi
Mucopolysaccharidosis II (Hunter syndrome)
Intrathecal
Phase 3 – BLA; Fast Track; Orphan Drug
TBD
inavolisib
Genentech
Breast cancer
Oral
Phase 3 – NDA
TBD
inclacumab
Global Blood Therapeutics
SCD
IV
Phase 3 – BLA; Orphan Drug
TBD
insulin aspart (biosimilar to Novo Nordisk’s Novolog®)
Sanofi
T1DM; T2DM
SC
Phase 3 – BLA
TBD
insulin glargine (biosimilar to Sanofi’s Lantus)
Gan & Lee
T1DM; T2DM
SC
Phase 3 – BLA
TBD
insulin icodec (onceweekly)
Novo Nordisk
T2DM
SC
Phase 3 – BLA
TBD
iodine-131 apamistamab
Actinium
AML
IV
Phase 3 – BLA; Orphan Drug
TBD
ipatasertib
Genentech
Prostate cancer
Oral
Phase 3 – NDA
TBD
iptacopan
Novartis
Complement 3 (C3) glomerulopathy; Hemolytic uremic syndrome; Immunoglobulin A nephropathy (Berger’s disease); PNH
Oral
Phase 3 – NDA; Breakthrough Therapy; Orphan Drug; Rare Pediatric Disease
TBD
itepekimab
Regeneron/Sanofi
COPD
SC
Phase 3 – BLA
TBD
Lactobacillus reuteri
Infant Bacterial Therapeutics
Necrotizing enterocolitis
Oral
Phase 3 – BLA; Orphan Drug
TBD
lanifibranor
Inventiva
NASH
Oral
Phase 3 – NDA; Breakthrough Therapy; Fast Track
TBD
lazertinib
Genosco
NSCLC
Oral
Phase 3 – NDA
TBD
lebrikizumab
Eli Lilly
Atopic dermatitis (moderate-severe)
SC
Phase 3 – BLA; Fast Track
TBD
lenadogene nolparvovec (GS010)
Gensight
Leber’s hereditary optic neuropathy
Intravitreal
Phase 3 – BLA; Orphan Drug
TBD
leniolisib
Pharming/Novartis
Activated phosphatidylinositol3-kinase (PI3K)-delta syndrome
Oral
Phase 3 – NDA; Orphan Drug
TBD
lenzilumab
Humanigen
COVID-19
IV
Phase 3 – BLA
TBD
leriglitazone
Minoryx
Adrenoleukodystrophy
Oral
Phase 3 – NDA; Fast Track; Orphan Drug; Rare Pediatric Disease
TBD
levodopa/carbidopa patch pump
Mitsubishi Tanabe
Parkinson’s disease
SC
Phase 3 – 505(b)(2) NDA
TBD
ligelizumab
Novartis
Urticaria
SC
Phase 3 – BLA; Breakthrough Therapy
TBD
linrodostat
Bristol-Myers Squibb
Bladder cancer
Oral
Phase 3 – NDA
TBD
lotilaner
Tarsus
Demodex blepharitis
Ophthalmic
Phase 3 – NDA
TBD
magrolimab
Gilead
Myelodysplastic syndrome
IV
Phase 3 – BLA; Breakthrough Therapy; Fast Track; Orphan Drug
TBD
marstacimab
Pfizer
Hemophilia A and B
IV, SC
Phase 3 – BLA; Fast Track; Orphan Drug
TBD
32 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
masitinib
AB Science
ALS; Alzheimer’s disease; Asthma (eosinophilic); Mastocytosis; MS
mavorixafor
X4
melphalan
FDA DESISION
Phase 3 – NDA; Orphan Drug
TBD
Warts, Oral hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome
Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Rare Pediatric Disease
TBD
Delcath
Uveal melanoma (hepatic-dominant)
Percutaneous hepatic perfusion
Phase 3 – NDA
TBD
meningococcal vaccine
GlaxoSmithKline
Meningococcal immunization
IM
Phase 3 – BLA
TBD
meningococcal vaccine
Pfizer
Meningococcal immunization
IM
Phase 3 – BLA
TBD
metachromatic leukodystrophy gene therapy
Orchard
Metachromatic leukodystrophy
IV
Phase 3 – BLA; Orphan Drug; RMAT
TBD
midomafetamine
Multidisciplinary Association for Psychedelic Studies
PTSD
Oral
Phase 3 – NDA; Breakthrough Therapy
TBD
minocycline
Journey
Rosacea
Oral
Phase 3 – 505(b)(2) NDA
TBD
minocycline/edetate/ethyl alcohol
Citius
Catheter-related bloodstream infection (CRBSI)
IV
Phase 3 – NDA; Fast Track; QIDP
TBD
mirikizumab
Eli Lilly
CD
IV, SC
Phase 3 – BLA
TBD
mitapivat
Agios
SCD; Thalassemia
Oral
Phase 3 – NDA; Orphan Drug
TBD
molnupiravir
Merck
COVID-19
Oral
Phase 3 – NDA
TBD
motixafortide
Biolinerx
Stem cell mobilization
SC
Phase 3 – NDA; Orphan Drug
TBD
nabiximols
Jazz
MS-related spasticity
Oral transmucosal
Phase 3 – NDA
TBD
nalbuphine ER
Trevi
Pruritus
Oral
Phase 3 – NDA; Fast Track
TBD
naloxone
Orexo
Opioid overdose
Intranasal
Phase 3 – 505(b)(2) NDA
TBD
naloxone hydrochloride dihydrate lotion
Elorac
Pruritus
Topical
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
narsoplimab
Omeros
Hemolytic uremic syndrome
IV, SC
Phase 3 – BLA; Fast Track
TBD
natalizumab (biosimilar to Biogen’s Tysabri®)
Novartis
MS
IV
Phase 3 – BLA
TBD
navitoclax
Abbvie/Genentech
Myelofibrosis
Oral
Phase 3 – NDA; Orphan Drug
TBD
nedosiran
Novo Nordisk
Hyperoxaluria
SC
Phase 3 – NDA; Breakthrough Therapy; Orphan Drug; Rare Pediatric Disease
TBD
nemolizumab
Galderma
Atopic dermatitis (moderate-severe); Pruritus
SC
Phase 3 – BLA; Breakthrough Therapy
TBD
nipocalimab
Janssen
Autoimmune hemolytic anemia
IV
Phase 3 – BLA; Fast Track; Orphan Drug
TBD
33 | MAGELLANRX.COM
Oral
DEVELOPMENT STATUS
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
nirmatrelvir/ritonavir (Paxlovid)
Pfizer
COVID-19
Oral
Phase 3 – NDA
TBD
nirsevimab
AstraZeneca
RSV prevention
IM
Phase 3 – BLA; Breakthrough Therapy; Fast Track
TBD
nomacopan
Akari
Bullous pemphigoid; Hemolytic uremic syndrome; HSCTassociated thrombotic microangiopathy; PNH
SC
Phase 3 – BLA; Fast Track; Orphan Drug
TBD
Novavax COVID-19 vaccine, adjuvanted
Novavax
COVID-19
IM
Phase 3 – BLA
TBD
olezarsen
Akcea
Familial chylomicronemia syndrome
SC
Phase 3 – NDA
TBD
oportuzumab monatox
Sesen
Bladder cancer (highrisk, BCG-unresponsive, nonmuscle invasive)
Intravesical
Phase 3 – BLA; Fast Track
TBD
OPT-302
Opthea
Wet AMD
Intravitreal
Phase 3 – BLA; Fast Track
TBD
OTL-103
Orchar
Wiskott-Aldrich syndrome IV
Phase 3 – BLA; Orphan Drug; RMAT
TBD
Oxalobacter formigenes
Oxthera
Hyperoxaluria
Oral
Phase 3 – BLA; Orphan Drug; Rare Pediatric Disease
TBD
padeliporfin
Steba
Bladder cancer
IV
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
palopegteriparatide
Ascendis
Hypoparathyroidism
SC
Phase 3 – BLA; Orphan Drug
TBD
pamrevlumab
Fibrogen
COVID-19; DMD; IV Idiopathic pulmonary fibrosis; Pancreatic cancer
Phase 3 – BLA; Fast Track; Orphan Drug; Rare Pediatric Disease
TBD
pegadricase
Swedish Orphan Biovitrum
Gout
IV
Phase 3 – BLA
TBD
pegzilarginase
Aeglea
Arginase 1 deficiency
IV
Phase 3 – BLA; Breakthrough Therapy; Fast Track; Orphan Drug
TBD
perfluorohexyloctane
Bausch
DED
Ophthalmic
Phase 3 – NDA
TBD
pirtobrutinib
Eli Lilly
Mantle cell lymphoma
Oral
Phase 3 – NDA
TBD
plinabulin
Beyondspring
Chemotherapy-induced neutropenia prevention; NSCLC
IV
Phase 3 – NDA; Breakthrough Therapy
TBD
plonmarlimab
I-Mab
COVID-19
IV
Phase 3 – BLA
TBD
pollinex quattro grass
Allergy Therapeutics
Allergic rhinitis
SC
Phase 3 – BLA
TBD
pollinex quattro ragweed
Allergy Therapeutics
Allergic rhinitis
SC
Phase 3 – BLA
TBD
potassium citrate/ potassium bicarbonate
Advicenne
Renal tubular acidosis
Oral
Phase 3 – 505(b)(2) NDA
TBD
pozelimab
Regeneron
PNH; Chaple disease
IV, SC
Phase 3 – BLA; Orphan Drug
TBD
pritelivir
Aicuris Anti-infective Cures
Herpes simplex virus treatment
Oral
Phase 3 – NDA; Breakthrough Therapy; Fast Track
TBD
prothrombin complex
Octapharma
Hemostasis
IV
Phase 3 – BLA
TBD
proxalutamide
Kintor
COVID-19
Oral
Phase 3 – NDA
TBD
34 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
rabies monoclonal antibody cocktail
Sanofi
Rabies treatment
IM
Phase 3 – BLA; Fast Track
TBD
ralinepag
United Therapeutics
PAH
Oral
Phase 3 – NDA; Orphan Drug
TBD
ranibizumab (biosimilar to Genentech’s Lucentis)
Stada Arzneimittel/ Bausch
Wet AMD; Macular edema following RVO; Myopic choroidal neovascularization (mCNV)
Intravitreal
Phase 3 – BLA
TBD
rapamycin
Timber
Tuberous sclerosis complex-associated facial angiofibromas
Topical
Phase 3 – NDA
TBD
rapamycin (high-strength)
Palvella
Pachyonychia congenita
Topical
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
REGN1908-1909
Regeneron
Allergic rhinitis
SC
Phase 3 – BLA
TBD
relacorilant
Corcept
Cushing’s syndrome
Oral
Phase 3 – NDA; Orphan Drug
TBD
reproxalap
Aldeyra
Allergic conjunctivitis; DED
Ophthalmic
Phase 3 – NDA
TBD
resmetirom
Madrigal/Roche
NASH
Oral
Phase 3 – NDA; Fast Track
TBD
rezafungin
Cidara
Candidemia/invasive candidiasis
IV
Phase 3 – NDA; Fast Track; TBD Orphan Drug; QIDP
ridinilazole
Summit
C. difficile-associated diarrhea
Oral
Phase 3 – NDA; Fast Track; QIDP
TBD
ritlecitinib
Pfizer
Alopecia areata
Oral
Phase 3 – NDA; Breakthrough Therapy
TBD
roflumilast cream
Arcutis/AstraZeneca
Atopic dermatitis (scalp)
Topical
Phase 3 – NDA
TBD
roluperidone
Minerva Neurosciences
Schizophrenia
Oral
Phase 3 – NDA
TBD
ropeginterferon alfa-2b
Pharmaessentia
Essential thrombocythemia
SC
Phase 3 – BLA; Orphan Drug
TBD
roxadustat
AstraZeneca
Anemia due to cytotoxic chemotherapy
Oral
Phase 3 – NDA
TBD
rozanolixizumab
UCB
Myasthenia gravis
SC
Phase 3 – BLA; Orphan Drug
TBD
RSV vaccine (GSK3844766A)
GlaxoSmithKline
RSV prevention
IM
Phase 3 – BLA; Fast Track
TBD
RSV vaccine (JNJ64400141)
Janssen
RSV prevention
IM
Phase 3 – BLA; Breakthrough Therapy
TBD
RSV vaccine (PF06928316)
Pfizer
RSV prevention
IM
Phase 3 – BLA; Breakthrough Therapy; Fast Track
TBD
ruxolitinib (deuterated)
Concert
Alopecia areata
Oral
Phase 3 – NDA; Breakthrough Therapy; Fast Track
TBD
sabatolimab
Novartis
Myelodysplastic syndrome
IV
Phase 3 – BLA; Fast Track
TBD
seasonal influenza nanoparticle vaccine
Novavax
Seasonal influenza prevention
IM
Phase 3 – BLA; Fast Track
TBD
sebetralstat
Kalvista
HAE
Oral
Phase 3 – NDA; Fast Track
TBD
seladelpar
Cymabay/Janssen
Primary biliary cholangitis Oral
Phase 3 – NDA; Breakthrough Therapy; Orphan Drug
TBD
35 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
seltorexant
Janssen
MDD
Oral
Phase 3 – NDA
TBD
sepofarsen
Proqr
Leber’s congenital amaurosis
Intravitreal
Phase 3 – NDA; Fast Track; Orphan Drug
TBD
sofpironium
Brickell
Axillary hyperhidrosis
Topical
Phase 3 – NDA
TBD
sotatercept
Merck/Bristol-Myers Squibb
PAH
SC
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug
TBD
sotrovimab
Vir
COVID-19
IV
Phase 3 – BLA
TBD
sparsentan
Travere/BristolMyers Squibb
Focal segmental glomerulosclerosis
Oral
Phase 3 – NDA; Orphan Drug
TBD
SPK-8011
Genentech
Hemophilia A
IV
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug
TBD
tabelecleucel
Atara
Epstein-Barr virus-associated post-transplant lymphoproliferative disease
IV
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug
TBD
TAK-755
Takeda
Thrombotic thrombocytopenic purpura (TTP)
IV
Phase 3 – BLA; Fast Track; Orphan Drug
TBD
tanfanercept
Hanall
DED
Ophthalmic
Phase 3 – BLA
TBD
tarcocimab tedromer
Kodiak
DME; Retinal vein occlusion-associated macular edema; Wet AMD
Intravitreal
Phase 3 – BLA
TBD
tecarfarin
Espero
Anticoagulation
Oral
Phase 3 – NDA
TBD
tiragolumab
Genentech
Esophageal cancer; NSCLC
IV
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug
TBD
tiratricol
Rare Thyroid Therapeutics
Resistance to thyroid hormone type beta (RTH-b)
Oral
Phase 3 – NDA; Fast Track; Orphan Drug; Rare Pediatric Disease
TBD
tislelizumab
Beigene
Gastric cancer; HCC; NSCLC
IV
Phase 3 – BLA; Orphan Drug
TBD
tixagevimab + cilgavimab (Evusheld)
AstraZeneca
COVID-19
IM
Phase 3 – BLA
TBD
tocilizumab (biosimilar to Genentech’s Actemra)
Biogen
RA
IV
Phase 3 – BLA
TBD
tocilizumab (biosimilar to Genentech’s Actemra)
Fresenius/Merck
RA
IV
Phase 3 – BLA
TBD
tofersen
Biogen
ALS
Intrathecal
Phase 3 – NDA; Orphan Drug
TBD
tominersen
Genentech
Huntington’s disease
Intrathecal
Phase 3 – NDA; Orphan Drug
TBD
tradipitant
Vanda/Eli Lilly
Atopic dermatitis; COVID-19; Emesis; Gastroparesis; Pruritus
Oral
Phase 3 – NDA
TBD
travoprost implant
Glaukos
Glaucoma/ocular hypertension
Intraocular
Phase 3 – NDA
TBD
TT-173
Thrombotargets
Hemostasis
Topical
Phase 3 – BLA; Orphan Drug
TBD
tusamitamab ravtansine
Sanofi
NSCLC
IV
Phase 3 – BLA
TBD
36 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
ustekinumab (biosimilar to Janssen’s Stelara)
Amgen
PSO
IV, SC
Phase 3 – BLA
TBD
ustekinumab (biosimilar to Janssen’s Stelara)
Formycon
PSO
IV, SC
Phase 3 – BLA
TBD
ustekinumab (biosimilar to Janssen’s Stelara)
Hikma
PSO
IV, SC
Phase 3 – BLA
TBD
ustekinumab (biosimilar to Janssen’s Stelara)
Intas
PSO
IV, SC
Phase 3 – BLA
TBD
vadadustat
Akebia
Anemia due to CKD (dialysis-dependent, dialysis-independent)
Oral
Phase 3 – NDA
TBD
valoctocogene roxaparvovec
Biomarin
Hemophilia A
IV
Phase 3 – BLA; Breakthrough Therapy; Orphan Drug; RMAT
TBD
venglustat
Sanofi
Gaucher’s disease; GM2 gangliosidoses (TaySachs disease, Sandhoff disease, AB variant)
Oral
Phase 3 – NDA; Orphan Drug
TBD
verbrinacogene setparvovec
Freeline
Hemophilia B
IV
Phase 3 – BLA; Orphan Drug; RMAT
TBD
VGX-3100 therapeutic vaccine
Inovio
Cervical dysplasia (human IM papillovirus-positive)
Phase 3 – BLA
TBD
visomitin
Mitotech
DED
Ophthalmic
Phase 3 – NDA
TBD
wilfactin
LFB
Von Willebrand disease
IV
Phase 3 – BLA; Orphan Drug
TBD
zavegepant
Biohaven/BristolMyers Squibb
COVID-19; Migraine prevention
Intranasal
Phase 3 – NDA
TBD
zilucoplan
UCB
Myasthenia gravis
SC
Phase 3 – NDA; Orphan Drug
TBD
zolbetuximab
Astellas
Gastric cancer
IV
Phase 3 – BLA; Orphan Drug
TBD
zoliflodacin
Entasis
Gonorrhea
Oral
Phase 3 – NDA; Fast Track; QIDP
TBD
zuranolone
Sage
MDD; Post-partum depression
Oral
Phase 3 – NDA; Breakthrough Therapy; Fast Track
TBD
Phase 3 (Supplementals) adalimumab (Hulio; biosimilar to Abbvie’s Humira)
Viatris/Biocon
Hidradenitis suppurativa; Uveitis
SC
Phase 3 – sBLA
TBD
Eli Lilly
JIA; Uveitis
Oral
Phase 3 – sNDA
TBD
benralizumab (Fasenra )
AstraZeneca
ANCA-associated vasculitis; Bronchiectasis; Bullous pemphigoid; Chronic rhinosinusitis with nasal polyps (CRSwNP); Esophagitis
SC
Phase 3 – sBLA; Orphan Drug
TBD
brexpiprazole (Rexulti®)
Otsuka
PTSD
Oral
Phase 3 – sNDA
TBD
dupilumab (Dupixent)
Sanofi
Allergic fungal rhinosinusitis; Bullous pemphigoid; COPD; Urticaria
SC
Phase 3 – sBLA; Orphan Drug
TBD
baricitinib (Olumiant) ®
37 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
efgartigimod (Vyvgart®)
Argenx
ITP; Myasthenia gravis; Pemphigus vulgaris
IV
Phase 3 – sBLA; Orphan Drug
TBD
empagliflozin (Jardiance®)
Boehringer Ingelheim
Diabetic nephropathy
Oral
Phase 3 – sNDA
TBD
ferric carboxymaltose (Injectafer®)
Daiichi Sankyo
Anemia in heart failure
IV
Phase 3 – sNDA
TBD
ferric derisomaltose (Monoferric®)
Pharmacosmos
Anemia in heart failure
IV
Phase 3 – sNDA
TBD
fostamatinib (Tavalisse®)
Rigel
Autoimmune hemolytic anemia
Oral
Phase 3 – sNDA; Fast Track; Orphan Drug
TBD
guselkumab (Tremfya®)
Janssen
UC
SC
Phase 3 – sBLA
TBD
hydrogen peroxide (Eskata®)
Aclaris
Warts
Topical
Phase 3 – sNDA
TBD
immune globulin intravenous (human) 10% (Octagam®)
Octapharma
COVID-19
IV
Phase 3 – sBLA
TBD
inebilizumab-cdon (Uplizna®)
Horizon
IgG4-related disease; Myasthenia gravis
IV
Phase 3 – sBLA
TBD
L-lactic acid/citric acid/ potassium bitartrate (Phexxi®)
Evofem
Chlamydia trachomatis infection; Neisseria gonorrhoeae infection
Intravaginal
Phase 3 – sNDA; Fast Track; QIDP
TBD
mepolizumab (Nucala®)
GlaxoSmithKline
COPD
IV, SC
Phase 3 – sBLA
TBD
meropenem/vaborbactam (Vabomere®)
Melinta
Bacteremia; HAP
IV
Phase 3 – sNDA; QIDP
TBD
nitazoxanide (Alinia®)
Lupin
COVID-19; Influenza
Oral
Phase 3 – sNDA
TBD
obeticholic acid (Ocaliva )
Intercept
NASH
Oral
Phase 3 – sNDA; Breakthrough Therapy
TBD
odevixibat (Bylvay™)
Albireo
Alagille syndrome-related Oral cholestatic pruritus
Phase 3 – sNDA; Orphan Drug
TBD
omalizumab (Xolair®)
Genentech
Food allergies
SC
Phase 3 – sBLA; Breakthrough Therapy
TBD
patisiran (Onpattro®)
Alnylam
Transthyretin amyloid cardiomyopathy (ATTR-CM, wild type or hereditary)
IV
Phase 3 – sNDA; Orphan Drug
TBD
pegylated liposomal irinotecan (Onivyde®)
Ipsen
SCLC
IV
Phase 3 – sNDA; Fast Track; Orphan Drug
TBD
ravulizumab-cwvz (Ultomiris)
Alexion
Pachyonychia congenita
IV, SC
Phase 3 – sBLA
TBD
risankizumab-rzaa (Skyrizi®)
Abbvie
UC
IV, SC
Phase 3 – sBLA
TBD
rituximab-arrx (biosimilar to Genentech’s Rituxan) (Riabni)
Amgen
RA
IV
Phase 3 – sBLA
TBD
rivaroxaban (Xarelto®)
Janssen
COVID-19
Oral
Phase 3 – sNDA
TBD
romiplostim (Nplate®)
Amgen
Chemotherapy-induced thrombocytopenia
SC
Phase 3 – sBLA; Orphan Drug
TBD
secukinumab (Cosentyx®)
Novartis
Hidradenitis suppurativa
IV, SC
Phase 3 – sBLA
TBD
tapinarof (Vtama®)
Roivant
Atopic dermatitis
Topical
Phase 3 – sNDA
TBD
tezepelumab-ekko (Tezspire™)
AstraZeneca
Nasal polyposis
SC
Phase 3 – sBLA
TBD
ticagrelor (Brilinta)
AstraZeneca
SCD
Oral
Phase 3 – sNDA
TBD
®
38 | MAGELLANRX.COM
PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DESISION
tirzepatide (Mounjaro™)
Eli Lilly
Obesity
SC
Phase 3 – sNDA
TBD
upadacitinib (Rinvoq)
Abbvie
CD; Giant cell arteritis
Oral
Phase 3 – sNDA
TBD
Complete Response Letter (CRL) NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
DEVELOPMENT STATUS
FDA DECISION
acetaminophen/ibuprofen
Hyloris
Postsurgical pain
IV
CRL
TBD
bimekizumab
UCB
PSO
IV, SC
CRL
TBD
cantharidin
Verrica
Molluscum contagiosum
Topical
CRL
TBD
meloxicam/rizatriptan
Axsome
Migraine treatment
Oral
CRL
TBD
setmelanotide (Imcivree®)
Rhythm
Alström (related obesity and hunger)
SC
CRL
TBD
surufatinib
Hutchmed
Neuroendocrine tumors
Oral
CRL
TBD
tebipenem pivoxil
Spero
UTI (complicated)
Oral
CRL
TBD
toripalimab
Coherus
Nasopharyngeal cancer (recurrent or metastatic, 1st-line in combination with chemotherapy, 2ndline monotherapy)
IV
CRL
TBD
39 | MAGELLANRX.COM
GLOSSARY 6MWT 6 Minute Walking Test
CF Cystic Fibrosis
ABSSSI Acute Bacterial Skin and Skin Structure Infection
CHF Congestive Heart Failure
ACEI Angiotensin-Converting Enzyme Inhibitor
CKD Chronic Kidney Disease
ACR20 American College of Rheumatology 20% Improvement ACR50 American College of Rheumatology 50% Improvement
CI Confidence Interval CLL Chronic Lymphocytic Leukemia CML Chronic Myeloid Leukemia CMS Centers for Medicare & Medicaid Services
ACR70 American College of Rheumatology 70% Improvement
CNS Central Nervous System
ADC Antibody-Drug Conjugate
COVID-19 Coronavirus Disease 2019
ADHD Attention Deficit Hyperactivity Disorder
CRC Colorectal Cancer
ADL Activities of Daily Living
CRL Complete Response Letter
AED Anti-Epileptic Drug
CRR Complete Response Rate
ALK Anaplastic Lymphoma Kinase
CSF Colony Stimulating Factor
ALL Acute Lymphoblastic Leukemia
CV Cardiovascular
ALS Amyotrophic Lateral Sclerosis
CVD Cardiovascular Disease
ALT Alanine Transaminase AMD Age-Related Macular Degeneration
DAS28-CRP Disease Activity Score-28 with C Reactive Protein
AML Acute Myeloid Leukemia
DEA Drug Enforcement Administration
ANCA Antineutrophil Cytoplasmic Antibodies
DLBCL Diffuse Large B Cell Lymphoma
ANDA Abbreviated New Drug Application
DMARD Disease Modifying Antirheumatic Drug
ARB Angiotensin II Receptor Blocker
DMD Duchenne Muscular Dystrophy
ARNI Angiotensin Receptor II Blocker – Neprilysin Inhibitor
DME Diabetic Macula Edema
ART Antiretroviral Therapy
DNA Deoxyribonucleic Acid
ARV Antiretroviral
DOR Duration of Response
AS Ankylosing Spondylitis
DPI Dry Powder for Inhalation
ASCVD Atherosclerotic Cardiovascular Disease
DPP-4 Dipeptidyl Peptidase 4
AST Aspartate Aminotransferase
DR Delayed-Release
BCVA Best Corrected Visual Acuity BLA Biologics License Application
EASI-75 Eczema Area and Severity Index ≥ 75% Reduction
BMI Body Mass Index
ECOG Eastern Cooperative Oncology Group
BSA Body Surface Area
EDSS Expanded Disability Status Scale
BsUFA Biosimilar User Fee Act
eGFR estimated Glomerular Filtration Rate
CABP Community Acquired Bacterial Pneumonia
EGFR Epidermal Growth Factor Receptor
CAP Community Acquired Pneumonia
ER Extended-Release
CAR T Chimeric Antigen Receptor T Cell
ESA Erythropoietin Stimulating Agent
CD Crohn's Disease
ESRD End-Stage Renal Disease
CDC Centers for Disease Control and Prevention
EUA Emergency Use Authorization
40 | MAGELLANRX.COM
COPD Chronic Obstructive Pulmonary Disease
DMT Disease Modifying Therapy
GLOSSARY continued FDA Food and Drug Administration
IRB Internal Review Board
FH Familial Hypercholesterolemia
ITP Immune Thrombocytopenic Purpura
FLT3 FMS-Like Tyrosine Kinase-3
ITT Intent-To-Treat
G-CSF Granulocyte Colony Stimulating Factor
IV Intravenous
GI Gastrointestinal
JIA Juvenile Idiopathic Arthritis
GIST Gastrointestinal Stromal Tumor
LDL Low-Density Lipoprotein
GLP-1RA Glucagon-Like Peptide-1 Receptor Agonist
LDL-C Low-Density Lipoprotein Cholesterol
GM-CSF Granulocyte-Macrophage Colony Stimulating Factor
LVEF Left Ventricular Ejection Fraction
GVHD Graft Versus Host Disease
MACE Major Adverse Cardiovascular Events
H Half HAART Highly Active Antiretroviral Therapy HAM-D Hamilton Depression Rating Scale HAP Healthcare-Associated Pneumonia Hb Hemoglobin HbA1c Hemoglobin A1c HBV Hepatitis B Virus HCC Hepatocellular Carcinoma HCP Healthcare Professional HCV Hepatitis C Virus HER Human Epidermal Growth Factor Receptor HER2 Human Epidermal Growth Factor Receptor 2 HF Heart Failure HFA Hydrofluoroalkane HFpEF Heart Failure with preserved Ejection Fraction HIT Heparin Induced Thrombocytopenia HIV Human Immunodeficiency Virus HIV-1 Human Immunodeficiency Virus-1 HPV Human Papilloma Virus HR Hazard Ratio HSCT Hematopoietic Stem Cell Transplant HTN Hypertension IBS Irritable Bowel Syndrome IBS-C Irritable Bowel Syndrome, Constipation Predominant IGA Investigator's Global Assessment IL-12 Interleukin-12 IL-17 Interleukin-17 IL-23 Interleukin-23 IM Intramuscular
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mAb Monoclonal Antibody MADRS Montgomery – Åsberg Depression Rating Scale MAOI Monoamine Oxidase Inhibitor MDD Major Depressive Disorder MDI Metered Dose Inhaler MDR Multi-Drug Resistant mITT modified Intent-To-Treat MRI Magnetic Resonance Imaging MRSA Methicillin-Resistant Staphylococcus Aureus MS Multiple Sclerosis N/A Not Applicable NASH Non-Alcoholic Steatohepatitis NCCN National Comprehensive Cancer Network NCT National Clinical Trials NDA New Drug Application NHL Non-Hodgkin Lymphoma NIAID National Institute of Allergy and Infectious Diseases NSAID Non-Steroidal Anti-Inflammatory Drug NSCLC Non-Small Cell Lung Cancer NYHA New York Heart Association ODT Orally Disintegrating Tablet OR Odds Ratio ORR Overall/Objective Response Rate OS Overall Survival OTC Over-the-Counter PAH Pulmonary Arterial Hypertension PARP Poly(ADP-ribose) Polymerase PAS Prior Approval Supplement PASI Psoriasis Area and Severity Index PASI 50 Psoriasis Area and Severity Index 50% Reduction PASI 75 Psoriasis Area and Severity Index 75% Reduction
GLOSSARY continued PASI 90 Psoriasis Area and Severity Index 90% Reduction
SCLC Small Cell Lung Cancer
PASI 100 Psoriasis Area and Severity Index 100% Reduction
SGLT2 Sodium-Glucose Co-Transporter 2
PCI Percutaneous Coronary Intervention PCSK9 Proprotein Convertase Subtilisin Kexin 9 PD-1 Programmed Death Protein 1 PD-L1 Programmed Death-Ligand 1 PDUFA Prescription Drug User Fee Application PFS Progression-Free Survival PGA Physician Global Assessment PHI Primary Humoral Immunodeficiency PNH Paroxysmal Nocturnal Hemoglobinuria PsA Psoriatic Arthritis PSO Plaque Psoriasis PTCA Percutaneous Transluminal Coronary Angioplasty PTSD Post-Traumatic Stress Disorder Q Quarter QIDP Qualified Infectious Diseases Product QOL Quality of Life R/R Relapsed or Refractory R-CHOP Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
SCT Stem Cell Transplant SL Sublingual SLE Systemic Lupus Erythematosus SLL Small Lymphocytic Lymphoma sNDA supplemental New Drug Application SNRI Serotonin and Norepinephrine Reuptake Inhibitor SOC Standard of Care sPGA static Physician Global Assessment SR Sustained-Release SSRI Selective Serotonin Reuptake Inhibitor SSSI Skin and Skin Structure Infection T1DM Type 1 Diabetes Mellitus T2DM Type 2 Diabetes Mellitus TBD To Be Determined TEAE Treatment-Emergent Adverse Event TNBC Triple Negative Breast Cancer TNF Tumor Necrosis Factor TNFα Tumor Necrosis Factor-alpha UA Unstable Angina UC Ulcerative Colitis
RA Rheumatoid Arthritis
US United States
RBC Red Blood Cell
UTI Urinary Tract Infection
RCC Renal Cell Carcinoma
VAS Visual Analog Scale
REMS Risk Evaluation and Mitigation Strategy
VEGF Vascular Endothelial Growth Factor
RMAT Regenerative Medicine Advanced Therapy
VTE Venous Thromboembolism
RNA Ribonucleic Acid
WBC White Blood Cell
RRR Relative Risk Reduction
WHO World Health Organization
RSV Respiratory Syncytial Virus
XR Extended-Release
RTOR Real-Time Oncology Review RVO Retinal Vein Occlusion SARS-CoV-2 Severe Acute Respiratory SyndromeAssociated Coronavirus-2 sBLA supplemental Biologics License Application SC Subcutaneous SCCHN Squamous Cell Cancer of the Head and Neck SCD Sickle Cell Disease
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MRx PIPELINE A VIEW INTO UPCOMING SPECIALTY & TRADITIONAL DRUGS
JANUARY 2022
2022 Magellan Rx Management, LLC. All rights reserved. MRX1119_0722