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AUGUST 2020

CLINICAL

ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS

EDITORIAL STAFF EDITOR IN CHIEF Maryam Tabatabai PharmD

TRENDING TOPICS

COVID-19 UPDATE

BEHAVIORAL HEALTH CORNER

DRUG INFORMATION HIGHLIGHTS

PIPELINE NEWS

RECENT FDA APPROVALS

EXECUTIVE EDITOR Anna Schreck Bird PharmD DEPUTY EDITORS Jessica Czechowski PharmD Lara Frick PharmD, BCPS, BCPP Carole Kerzic RPh Leslie Pittman PharmD


TRENDING TOPICS NEW INJECTABLE BREAST CANCER THERAPY FOR AT-HOME ADMINISTRATION The United States (US) Food and Drug Administration (FDA) has approved a new combination injectable product containing pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™) for the treatment of certain patients with either early breast cancer (EBC) or metastatic breast cancer (MBC). Pertuzumab and trastuzumab are human epidermal growth factor receptor 2 (HER2)/neu receptor antagonists. Hyaluronidase-zzxf is an endoglycosidase that enhances the dispersion and absorption of the other 2 co-administered medications, allowing for subcutaneous (SC) administration by a healthcare professional (HCP). In EBC, Phesgo is indicated for use in combination with chemotherapy for the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for EBC and as adjuvant treatment for adults with HER2positive EBC who are at high risk of recurrence. In MBC, Phesgo is indicated for use in combination with docetaxel for adults with HER2-positive MBC who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. In both EBC and MBC, patients should be selected based on an FDA-approved companion diagnostic test. The dosing regimen is dependent on the indication (neoadjuvant EBC, adjuvant EBC, or MBC). Phesgo is supplied as a solution in a single-dose vial (SDV) in 2 strengths: 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase/15 mL (80 mg, 40 mg, and 2,000 units/mL) or 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase/10 mL (60 mg, 60 mg, and 2,000 units/mL). It is for SC use only and is administered into the thigh by an HCP. It is not for intravenous (IV) administration and has different dosage and administration directions than IV pertuzumab, IV 2 | AUGUST 2020

trastuzumab, and SC trastuzumab when administered separately. The first dose of Phesgo is administered over approximately 8 minutes, with maintenance doses administered over approximately 5 minutes every 3 weeks. No dosage adjustments are needed based on body weight or concurrent chemotherapy agents. Patients are required to be observed for at least 30 minutes following the first dose and for 15 minutes following each maintenance dose, due to the potential for hypersensitivity or injection-related reactions. Emergency equipment and medications for the management of these reactions are required to be readily available. Approval for use in EBC was based on findings from the open-label, multicenter, non-inferiority, randomized FeDeriCa study in 500 HER2-positive EBC patients. Overall, Phesgo was found to be non-inferior and demonstrated similar safety to IV pertuzumab (Perjeta®) and IV trastuzumab (Herceptin®), with the exception of administration-related reactions, which were higher with Phesgo. Phesgo has boxed warnings for cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity. In addition, it is contraindicated in patients with a hypersensitivity to pertuzumab, trastuzumab, hyaluronidase, or any of the excipients. Phesgo is available from Genentech.

NEW APPROVAL FOR RARE DISEASE: NMOSD Viela Bio’s inebilizumab-cdon (Uplizna™) received US FDA approval for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are antiaquaporin-4 (AQP4) antibody-positive. Inebilizumab-cdon is a CD19-directed cytolytic antibody and is the second FDA approved therapy for the rare disease. Eculizumab (Soliris®), a complement inhibitor, is also FDA-approved for the treatment of NMOSD in adults who are AQP4 antibody-positive. NMOSD can be related to antibodies binding to the AQP4 protein and activating the immune system, leading to inflammation and detrimental effects in the central nervous system (CNS).


TRENDING TOPICS continued

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NMOSD is an autoimmune condition affecting the spinal cord and optic nerves, with onset generally occurring in adults, though symptoms may begin earlier. The majority of individuals with NMOSD experience symptoms in clusters that can be separated by days, months, or years, with intermittent periods of remission and incomplete recovery. However, some patients experience a single attack that may continue for months. It is estimated that 4,000 to 8,000 individuals in the US have NMOSD and that about half of these patients experience irreversible visual impairment and paralysis. Attacks usually include symptoms of optic neuritis, such as eye pain and vision loss. Other symptoms can include numbness, weakness, or paralysis in the arms or legs, and the inability to control the bladder or bowel.

mechanical ventilation, as well as in patients requiring supplemental oxygen. Furthermore, dexamethasone is recommended against in patients with COVID-19 who do not require supplemental oxygen. For additional clinical considerations, visit the NIH website.

Inebilizumab-cdon is supplied as a solution in an SDV in the strength of 100 mg/10 mL for dilution and IV administration, titrated to completion over about 90 minutes, with a recommended starting dose of 300 mg, followed 2 weeks later by another 300 mg dose. Subsequent single 300 mg doses begin 6 months after the first infusion and are given every 6 months thereafter. Careful patient monitoring is required during the infusion and for a minimum of 1 hour following completion.

The FDA has introduced a collaboration with Critical Path Institute (C-Path) and the NIH’s National Center for Advancing Translational Sciences (NCATS) for the CURE Drug Repurposing Collaboratory (CDRC) initiative. In the pilot program, CDRC will be using information collected from CURE ID to compile treatment responses in order to identify current drugs that may be useful treatments for COVID-19. The FDA has also announced that they are preparing for prioritized domestic inspections to resume with use of a new rating system to evaluate the COVID-19 risk in an effort to conduct these inspections in the safest possible manner.

Both FDA-approved drugs for NMOSD, inebilizumab-cdon and eculizumab, are indicated specifically for adults who are AQP4 antibody-positive. Eculizumab is also given by IV infusion with a dosing regimen of 900 mg weekly for the first 4 weeks, followed by 1,200 mg for the fifth dose 1 week later, then 1,200 mg every 2 weeks thereafter. In contrast to inebilizumab-cdon, eculizumab also carries additional indications and a boxed warning of the potential for serious meningococcal infections.

COVID-19: NOTABLE DEVELOPMENTS The National Institutes of Health (NIH) has updated their treatment guidelines on the novel coronavirus infection (COVID-19) to include recommendations on the use of the corticosteroid dexamethasone. These updates are based on study findings from the large, multicenter, randomized, open-label Randomised Evaluation of COVid-19 thERapY (RECOVERY) study conducted in hospitalized patients in the United Kingdom (UK). On the basis of study results, dexamethasone (6 mg per day for up to 10 days) is recommended in patients with COVID-19 who require

The NIH has launched a new clinical trials network, the COVID-19 Prevention Trials Network (COVPN), in an effort to recruit thousands of individuals for clinical studies evaluating investigational agents including vaccines and monoclonal antibodies. The COVPN was formed through merging 4 existing clinical trial networks and is a component of “Operation Warp Speed.” COVPN will manage over 100 trial sites globally to identify therapies for preventing COVID-19.

At the Virtual COVID-19 Conference, part of the 23rd International AIDS Conference, Gilead presented data on their investigational antiviral drug remdesivir. A pre-planned analysis was conducted comparing patients in the phase 3 SIMPLE-Severe study (n=312) with patients in a real-world retrospective cohort who received standard of care (SOC) (n=818). Data showed that remdesivir was associated with a 62% decrease in mortality, compared to SOC. At day 14, the mortality rate for remdesivir-treated patients was 7.6% versus 12.5% (adjusted odds ratio 0.38, 95% confidence interval [CI] 0.22 to 0.68, p=0.001). For more resources on COVID-19, visit the Magellan Rx Coronavirus Update webpage. For the most current information, visit the FDA, the Centers for Disease Control and Prevention (CDC), the NIH, and the World Health Organization (WHO) websites. State and local health departments also provide valuable information regarding management in local communities.


BEHAVIORAL HEALTH

CORNER NEW GAME-BASED DIGITAL THERAPEUTIC

SCREENING FOR UNHEALTHY DRUG USE

The FDA has granted clearance to the first game-based digital therapeutic device for attention deficit hyperactivity disorder (ADHD) and the first digital therapeutic designed to improve ADHD symptoms. The prescription device, EndeavorRx™, is indicated for patients 8 to 12 years of age with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. EndeavorRx is to be used as a component of a therapeutic program that could also involve clinician-directed therapy, pharmacotherapy, and educational programs.

The US Preventive Services Task Force (USPSTF) has issued a final recommendation statement on screening for unhealthy drug use. For adults age ≥ 18 years, it is recommended to screen by asking questions about unhealthy drug use, with screening implemented when services for accurate diagnosis, effective treatment, and appropriate care can be offered or referred (Grade B). For adolescents, the current evidence is insufficient to determine the benefits and harms of screening for unhealthy drug use (Grade I). To view the recommendation in its entirety, visit: uspreventiveservicestaskforce.org.

It is estimated that 4 million children between the ages of 6 to 11 years have ADHD. Commonly beginning in childhood, it may present as challenges with focus and attention, problems controlling behavior, and increased activity. The CDC recommends diagnosis be made by a trained HCP and include an assessment of symptoms (e.g., inattention, hyperactivity, and impulsivity) and interference with the individual’s ability to function. The device is indicated to increase attention as assessed by computer-based testing and was evaluated in multiple studies in > 600 children. Patients showed increased attention as determined by various measures such as the Test of Variables of Attention and educational performance assessments. In terms of safety, no serious adverse events occurred, but the most frequent adverse events were frustration, headache, dizziness, emotional reaction, and aggression. The FDA utilized the De Novo premarket review pathway that allows for evaluation of low or moderate risk new devices. As a result of the FDA’s marketing approval of EndeavorRx, subsequent similar devices for the same use can seek approval through the 510(k) premarket notification process, allowing for devices to receive marketing authorization through demonstration of equivalence to an established device. For additional details on Akili Interactive’s EndeavorRx, visit their website. 4 | AUGUST 2020

PILOT PROGRAM TARGETING UNAPPROVED OPIOIDS The FDA and the National Telecommunications and Information Administration (NTIA) will be launching a 120-day pilot program to aid in mitigating the availability of unapproved opioids illegally sold online. The NTIA is a branch of the US Department of Commerce and is responsible for telecommunications. They will work with internet registries involved in the pilot who will be receiving notification from the FDA when a warning letter is sent to a website operator and the operator does not respond within the given timeline. The internet registries will evaluate the information provided by the FDA and decide if voluntary action such as domain name suspensions or blocks should be implemented. For additional information on the new pilot program, visit the FDA website.


DRUG INFORMATION

HIGHLIGHTS • Granules Pharmaceuticals has issued voluntary recalls of 12 lots of metformin hydrochloride (HCl) extendedrelease (ER) tablets USP, 750 mg, within expiration to the consumer level, due to N-Nitrosodimethylamine (NDMA) levels greater than the acceptable daily intake (ADI) limit. Additionally, Lupin Pharmaceuticals has issued voluntary recalls of all batches of metformin HCl ER tablets USP, 500 mg and 1,000 mg to the consumer level, also due to NDMA. NDMA is an environmental contaminant and is considered to be a probable human carcinogen, based on laboratory findings. • A new single-dose pre-filled pen presentation of dupilumab (Dupixent®) in the strength of 300 mg/2 mL solution has received FDA approval. Previously, dupilumab was only available as a single-dose pre-filled syringe in the strengths of 300 mg/2 mL solution and 200 mg/ 1.14 mL solution. The pre-filled pen is only for use in adults and adolescents aged ≥ 12 years; the pre-filled syringe should be administered by a caregiver in children 6 to 11 years. • The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has selected viruses for the composition of the influenza vaccines for the 2020 to 2021 flu season. The quadrivalent formulation of eggbased influenza vaccines is recommended to contain the following: A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09-like virus, A/HongKong/2671/2019 (H3N2)-like virus, B/Washington/02/2019-like virus (B/ Victoria lineage), and B/Phuket/3073/2013-like virus (B/ Yamagata lineage). The quadrivalent formulation of cell- or recombinant-based influenza vaccines is recommended to contain the following: A/Hawaii/70/2019 (H1N1) pdm09-like virus, A/HongKong/45/2019 (H3N2)-like virus, B/Washington/02/2019-like virus (B/Victoria lineage), and B/Phuket/3073/2013-like virus (B/Yamagata lineage). For trivalent vaccines, depending on the manufacturing method, A(H1N1) pdm09, A(H3N2), and B/Victoria lineage viruses as described above are recommended.

• The American Cancer Society (ACS) has provided updated 2020 guidelines on human papillomavirus (HPV) vaccination. The ACS has published an adaptation of the current Advisory Committee on Immunization Practices (ACIP) recommendations. Routine HPV vaccination between ages 9 to 12 years is expected to result in higher on-time vaccination rates; HCPs are encouraged to start offering the vaccine at age 9 or 10 years. Catch-up HPV vaccination is recommended for persons through age 26 years who are not sufficiently vaccinated; however, HCPs should inform those aged 22 to 26 years who have not been previously fully vaccinated that vaccination at older ages has less efficacy in reducing cancer risk. Furthermore, catch-up HPV vaccination is not recommended for adults > 26 years as ACS does not endorse the 2019 ACIP recommendation on shared decision making for adults 27 to 45 years, due in part to low efficacy and low cancer prevention. • GlaxoSmithKline (GSK) Consumer Healthcare has voluntarily recalled, to the retail level, 2 lots of Children’s Robitussin® Honey Cough and Chest Congestion DM (dextromethorphan/guaifenesin) and 1 lot of Children’s Dimetapp® Cold and Cough (brompheniramine/ dextromethorphan/phenylephrine) due to the inclusion of incorrect dosing cups. The dosing cups for the Children’s Robitussin product are missing the 5 mL and 10 mL graduations, and the dosing cups for the Children’s Dimetapp product are missing the 10 mL graduation. The dosing cups supplied with the products only contain the 20 mL graduation which could potentially result in accidental overdose of either product. • The FDA has announced the launch of Project Patient Voice, a new pilot program to address patient-reported outcomes from cancer clinical trials. The initiative includes a new website allowing for the public to find information on patient-reported symptoms from marketed cancer therapies.


PIPELINE

NEWS

UPCOMING PRESCRIPTION DRUG/BIOSIMILAR USER FEE ACT (PDUFA/BsUFA) DATES DRUG NAME MANUFACTURER

FORMULATION THERAPEUTIC CLASS

PROPOSED CLINICAL USE

ANTICIPATED FDA APPROVAL

oliceridine Trevena

• IV • Opioid agonist

Acute pain

August 7, 2020

sodium thiosulfate Fennec

• IV • Chelating agent

Cisplatin-induced ototoxicity

August 10, 2020

satralizumab Genentech

• SC • Interleukin-6 (IL-6) receptor inhibitor

Neuromyelitis optica (Devic’s syndrome)

August 14, 2020

filgotinib Gilead

• Oral • Janus kinase inhibitor

Rheumatoid arthritis

August 19, 2020

valoctocogene roxaparvovec Biomarin

• IV • Coagulation factor VIII gene therapy

Hemophilia A

August 21, 2020

veverimer Tricida

• Oral • Acid binder

Metabolic acidosis related to chronic kidney disease

August 21, 2020

risdiplam Genentech

• Oral • Survival of motor neuron-2 (SMN2) splicing modifier

Spinal muscular atrophy (SMA)

August 24, 2020

clascoterone Cassiopea

• Topical • Antiandrogen

Acne vulgaris

August 27, 2020

azacitidine Bristol-Myers Squibb

• Oral • Hypomethylating agent

Acute myelogenous leukemia (AML)

September 3, 2020

IV = intravenous; SC = subcutaneous

6 | AUGUST 2020


RECENT FDA

APPROVALS DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs metoclopramide HCl (Gimoti™) Evoke

• 505(b)(2) NDA approval 06/19/2020 • Indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis; it is not recommended for use in pediatric patients, due to the potential for tardive dyskinesia (TD) and extrapyramidal symptoms, as well as the potential for methemoglobinemia in neonates; it is also not recommended in patients with moderate to severe hepatic impairment (Child-Pugh B or C), patients with moderate to severe renal impairment (creatinine clearance < 60 mL/minute), and patients concomitantly using strong CYP2D6 inhibitors, due to the potential for increased drug levels and adverse reactions • Dopamine-2 (D2) antagonist • Nasal spray: 15 mg per 70 μL spray • Recommended dosage in patients < 65 years of age is 1 spray in 1 nostril 30 minutes before each meal and at bedtime (maximum, 4 sprays/day) for 2 to 8 weeks, depending on symptomatic response; it is not recommended as an initial therapy in patients ≥ 65 years of age, but those receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to the dosage described above • Boxed warning for tardive dyskinesia • Product availability is expected in 4Q 2020

fenfluramine HCl (Fintepla®) Zogenix

• 505(b)(2) NDA approval 06/25/2020; Orphan Drug, Priority Review • Indicated for the treatment of seizures associated with Dravet syndrome in patients ≥ 2 years of age • Precise anticonvulsant mechanism is unknown • Oral solution: 2.2 mg/mL • Recommended initial dosage is 0.1 mg/kg orally twice daily with or without food, which can be increased weekly based on efficacy and tolerability; the maximum dose is 0.35 mg/kg twice daily in those not on stiripentol (maximum, 26 mg); the maximum dose is 0.2 mg/kg twice daily in those on stiripentol and clobazam (maximum, 17 mg) • Boxed warning for valvular heart disease and pulmonary arterial hypertension • Schedule IV controlled substance

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs continued octreotide (Mycapssa®) Chiasma

• 505(b)(2) NDA approval 06/26/2020; Orphan Drug • Indicated for long-term maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide • Somatostatin analog • Delayed-release capsules: 20 mg • Recommended initial dosage is 20 mg orally twice daily; titrate based on insulin-like growth factor 1 (IGF-1) levels and patient’s signs and symptoms every 2 weeks, or as indicated, in increments of 20 mg (maximum, 80 mg/day) • Product availability is expected in 4Q 2020

pertuzumab/ trastuzumab/ hyaluronidase-zzxf (Phesgo™) Genentech

• BLA approval 06/29/2020; Assessment Aid • Indicated for combination use » with chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer » with chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence » with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease • Fixed-dose combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase • Injection: 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase per 15 mL (80 mg/mL, 40 mg/mL, and 2,000 units/mL); 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase per 10 mL (60 mg/mL, 60 mg/mL, and 2,000 units/mL); available as solutions for injection in SDVs • Recommended initial dosage is 1,200 mg pertuzumab/600 mg trastuzumab/ 30,000 units hyaluronidase SC over approximately 8 minutes, followed by a dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC over approximately 5 minutes every 3 weeks; administer to thigh only; dosing differs from other IV pertuzumab and trastuzumab products; patients on IV pertuzumab and trastuzumab can transition to Phesgo maintenance dose with < 6 weeks since the last IV dose; after completion of the chemotherapy regimen, Phesgo may be HCP-administered in the home setting • As part of a complete regimen, neoadjuvant treatment should continue for 3 to 6 cycles and following surgery, for a total of 1 year of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs 1st; adjuvant treatment should continue for a total of 1 year of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs 1st; metastatic breast cancer treatment should continue until disease progression or unmanageable toxicity, whichever occurs 1st • Boxed warnings for cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.

8 | AUGUST 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs continued triheptanoin (Dojolvi™) Ultragenyx

• 505(b)(2) NDA approval 06/30/2020; Orphan Drug • Indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) • Medium-chain triglyceride • Oral liquid: 100% w/w solution in 500 mL bottles • Recommended target daily dosage is ≤ 35% of the patient’s total prescribed daily caloric intake, divided into ≥ 4 doses, and administered orally diluted with foods, liquids, or formula via a silicone or polyurethane feeding tube

fostemsavir (Rukobia) Viiv

• NDA approval 07/02/2020; Breakthrough Therapy, Priority Review • Indicated for use in combination with other antiretrovirals (ARVs) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatmentexperienced adults with multidrug-resistant HIV-1 infection who are failing their current ARV regimen due to resistance, intolerance, or safety considerations • HIV-1 gp120-directed attachment inhibitor • Extended-release tablets: 600 mg • Recommended dosage is 1 tablet orally twice daily with or without food

adalimumab-fkjp (Hulio®) Mylan

• BLA approval 07/06/2020; Biosimilar to Abbvie’s Humira® • Indicated for: » adults with moderately to severely active rheumatoid arthritis (RA) » moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ≥ 4 years of age » adults with active psoriatic arthritis (PsA) » adults with active ankylosing spondylitis (AS) » adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy and in these patients who have also lost response to or are intolerant to infliximab products » adults with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants, such as corticosteroids, azathioprine, or 6-mercaptopurine (6-MP) » adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy/phototherapy for whom alternatives are less appropriate • Tumor necrosis factor (TNF) antagonist • Injection: Single-dose pre-filled pen, 40 mg/0.8 mL; single-dose pre-filled plastic syringe, 20 mg/0.4 mL and 40 mg/0.8 mL • Recommended dosage is dependent on indication; administered via SC injection; may be self- or caregiver-injected, following appropriate training • Boxed warnings for serious infections and malignancy • Product availability is expected in July 2023

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs continued decitabine/cedazuridine (Inqovi®) Otsuka

• NDA approval 07/07/2020; Assessment Aid, Orphan Drug, Priority Review • Indicated for the treatment of adults with myelodysplastic syndromes (MDS), including previously treated and untreated de novo and secondary MDS with specific French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups • Fixed-dose combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor • Tablets: 35 mg decitabine/100 mg cedazuridine • Recommended dosage is 1 tablet orally once daily on an empty stomach on days 1 through 5 of each 28-day cycle

oxymetazoline HCl (Upneeq™) RVL/Osmotica

• 505(b)(2) NDA approval 07/08/2020 • Indicated for the treatment of acquired blepharoptosis in adults • Alpha adrenoceptor agonist • Ophthalmic solution: 0.1% oxymetazoline HCl in 0.3 mL in single patient-use containers • Recommended dosage is 1 drop into 1 or both ptotic eye(s) once daily • Product availability to select ophthalmologists and optometrists is expected beginning in August 2020 through an early experience program

calcipotriene/ betamethasone dipropionate (Wynzora®) MC2

• 505(b)(2) NDA approval 07/20/2020 • Indicated for the topical treatment of plaque psoriasis in patients ≥ 18 years of age • Combination of a vitamin D analog and a corticosteroid • Topical cream: 0.005%/0.064% of calcipotriene/betamethasone dipropionate • Recommended dosage is applied to the affected areas once daily for up to 8 weeks and rubbed in gently to allow for the plaques to be saturated; maximum dose of 100 g per week; therapy should be discontinued once control is achieved • Product availability is expected 1Q 2021

calcium/magnesium/ potassium/sodium oxybates (Xywav™) Jazz

• NDA approval 07/21/2020; Orphan Drug, Priority Review • Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients ≥ 7 years of age with narcolepsy • CNS depressant • Oral solution: 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) • Recommended dosage for adults is an initial dose of 4.5 g per night orally, divided into 2 doses, then titrated in increments of up to 1.5 g per night per week to a recommended dosage range of 6 g to 9 g per night orally, with the 1st dose taken at bedtime and the 2nd dose taken 2.5 to 4 hours later; for pediatric patients, the starting dose, titration procedure, and maximum total nightly dose are dependent on body weight • Boxed warnings for CNS depression, abuse, and misuse • Schedule III controlled substance • Product availability is expected by the end of 2020 following Risk Evaluation and Mitigation Strategies (REMS) implementation

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.

10 | AUGUST 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

Expanded Indications tedizolid phosphate (Sivextro®) Merck

• sNDA approval 06/19/2020 • Expanded indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria to include pediatric patients ≥ 12 years of age » already indicated in adults with ABSSSI caused by designated susceptible bacteria • Recommended dosage is 200 mg administered once daily orally or as an IV infusion over 1 hour for 6 days

selinexor (Xpovio®) Karyopharm

• sNDA approval 06/22/2020; Accelerated Approval • New indication for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after ≥ 2 lines of systemic therapy » already indicated for use in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received ≥ 4 prior therapies and whose disease is refractory to ≥ 2 proteasome inhibitors, ≥ 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody • Recommended starting dose is 60 mg taken orally on days 1 and 3 of each week until disease progression or unacceptable toxicity

pembrolizumab (Keytruda®) Merck

• sBLA approvals 06/24/2020 and 06/29/2020; Accelerated Approval (only for every 6 week dosing) • New indications for: » the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation (06/24/2020) » the 1st-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (06/29/2020) » already indicated in select patients for the treatment of melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma (UC), subsequent line therapy for MSI-H or dMMR cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma (MCC), renal cell carcinoma (RCC), endometrial carcinoma, and tumor mutational burden-high cancer • Recommended dosages for these new indications are 200 mg as a 30-minute IV infusion every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

Expanded Indications continued coagulation factor IX, recombinant (Benefix®) Wyeth

• sBLA approval 06/26/2020 • New indication for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) » already indicated for adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, as well as perioperative management of bleeding » it is not indicated for induction of immune tolerance in patients with hemophilia B • Recommended dosage for the long-term prophylaxis against bleeding is 100 IU/kg once weekly; patients < 12 years of age have lower recovery, shorter half-life, and higher clearance (based on per kg body weight) compared to older patients; the dosing regimen (e.g., dose or frequency) should be adjusted based on clinical response • For IV administration, following reconstitution; not for administration by continuous infusion, as safety and efficacy for this route have not been established; initial administrations should be under medical supervision due to the potential for severe allergic reactions

avelumab (Bavencio®) EMD Serono

• sBLA approval 06/30/2020; Assessment Aid, Real-Time Oncology Review • Expanded indication for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with 1st-line platinum-containing chemotherapy » already indicated for select patients with MCC and RCC and select patients with locally advanced or metastatic UC who have disease progression following select treatments • Recommended dosage for UC is 800 mg every 2 weeks as an IV infusion over 60 minutes until disease progression or unacceptable toxicity (premedication with an antihistamine and acetaminophen needed for the first 4 infusions and as needed)

guselkumab (Tremfya®) Janssen

• sBLA approval 07/13/2020 • New indication for the treatment of adults with active PsA » already indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy • Recommended dosage for PsA is 100 mg SC at week 0, week 4, and every 8 weeks thereafter; it can be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate, and can be administered by an HCP or by a patient self-injecting following proper training

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.

12 | AUGUST 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

Expanded Indications continued sofosbuvir/velpatasvir (Epclusa®) Gilead

• sNDA approval 07/14/2020 • Expanded indication for the treatment of chronic hepatitis C virus (HCV) infection in treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A) » already indicated for adults and for pediatric patients ≥ 6 years of age or weighing ≥ 17 kg with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection: Š without cirrhosis or with compensated cirrhosis, and Š with decompensated cirrhosis for use in combination with ribavirin • Recommended dosage is 1 tablet (400 mg sofosbuvir and 100 mg velpatasvir) taken orally once daily with or without food for 12 weeks

capsaicin (Qutenza®) Averitas

• sNDA approval 07/17/2020 • New indication for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet » already indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) • Recommended dosage is a single, 30-minute application on the feet of up to 4 patches; treatment can be repeated every 3 months or as warranted by return of pain (but not more frequently than every 3 months); product should not be dispensed to patients for self-administration/handling, as only physicians or HCPs under the supervision of a physician should administer and handle the product

calcitriol (Vectical®) Galderma

• sNDA approval 07/17/2020 • Expanded indication for the topical treatment of mild to moderate plaque psoriasis in patients ≥ 2 years of age » already indicated for the topical treatment of mild to moderate plaque psoriasis in adults ≥ 18 years of age • Recommended dosage for all patients is to apply ointment to affected areas twice daily in the morning and evening; for pediatric patients 2 to 6 years of age, the maximum weekly dose is 100 g; for pediatric patients ≥ 7 years of age and for adults, the maximum weekly dose is 200 g

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.

References:

cancer.org

c-path.org

fda.gov

gilead.com

nih.gov

uspreventiveservicestaskforce.org

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MRx Clinical Alert - August 2020  

MRx Clinical Alert - August 2020  

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