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APRIL 2020

CLINICAL

ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS

EDITORIAL STAFF

EDITOR IN CHIEF

Maryam Tabatabai PharmD

TRENDING TOPICS

BEHAVIORAL HEALTH CORNER

BIOSIMILAR CORNER

DRUG INFORMATION HIGHLIGHTS

PIPELINE NEWS

RECENT FDA APPROVALS

EXECUTIVE EDITOR Carole Kerzic RPh

DEPUTY EDITORS

Jessica Czechowski PharmD Lara Frick PharmD, BCPS, BCPP Leslie Pittman PharmD Anna Schreck Bird PharmD


TRENDING TOPICS FDA APPROVAL OF NOVEL CHOLESTEROL LOWERING AGENT The United States (US) Food and Drug Administration (FDA) has approved Esperion’s new oral cholesterol lowering medication, bempedoic acid (Nexletol™). This first-in-class therapy is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Use of bempedoic acid for reducing cardiovascular (CV) morbidity and mortality has not been established. Statins and bempedoic acid both reduce cholesterol biosynthesis in the liver. Bempedoic acid inhibits adenosine triphosphate-citrate lyase (ACL), whereas statins inhibit 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Bempedoic acid is available as a 180 mg tablet with recommended dosing of 180 mg orally once daily with or without food. Approval of bempedoic acid was based on findings from 2 multicenter, randomized, double-blind, placebo-controlled, 52-week studies evaluating over 3,000 patients with HeFH or established ASCVD. In these studies, bempedoic acid was added to maximally tolerated statin therapy with or without other lipid-lowering agents. Patients treated with bempedoic acid demonstrated a significantly greater reduction in the mean change in LDL-C from baseline to week 12 compared to patients who received placebo. The mean reduction with bempedoic acid was 17% to 18% across the 2 studies. The maximum LDL-C reduction was seen by week 4. Bempedoic acid does not carry any contraindications for use but it does have the potential for causing increased serum uric acid levels (hyperuricemia), which 2 | APRIL 2020

can predispose patients to gout. In clinical studies, 1.5% and 0.4% of patients receiving bempedoic acid and placebo, respectively, experienced gout. The risk increased further for individuals with a past history of gout. Bempedoic acid also carries a warning regarding the potential for tendon rupture, which occurred in 0.5% of patients in clinical studies. Due to the potential for increased myopathy, bempedoic acid should not be used with simvastatin doses > 20 mg or pravastatin doses > 40 mg. Bempedoic acid has also received approval as a combination product with ezetimibe under the brand name Nexlizet™ (bempedoic acid/ezetimibe). This fixeddose tablet contains 180 mg of bempedoic acid and 10 mg of ezetimibe for once daily oral dosing with or without food. It carries the same FDA-approved indication as bempedoic acid. Approval was based on a multicenter, double-blind, randomized, placebocontrolled study that demonstrated a 38% reduction in the mean change in LDL-C from baseline to week 12 with bempedoic acid/ezetimibe compared to placebo in patients with HeFH, established ASCVD, or multiple risk factors for CV disease. Nexlizet carries the same precautions as Nexletol. Also manufactured by Esperion, Nexlizet is expected to be commercially available in July 2020; Nexletol became available March 30, 2020. These novel agents join the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors as options for lowering LDL-C in patients who do not reach goal with diet and maximally tolerated statin therapy. Notably, in non-comparative trials, PCSK9 inhibitors led to greater LDL-C lowering (range, 55% to 59%) than that seen with bempedoic acid (range, 17% to 18%) and demonstrated a 15% CV risk reduction as add-on to statin therapy. CV outcomes data for bempedoic acid are expected in early 2022.


TRENDING TOPICS continued UPDATED GUIDANCE ON MANAGEMENT OF ULCERATIVE COLITIS (UC) The American Gastroenterological Association (AGA) has published updated clinical practice guidelines regarding the management of moderate to severe UC. Patients with moderate to severe disease are considered to be patients who are dependent on or refractory to corticosteroids, exhibit ulcers upon endoscopic assessment, or who are at high risk for colectomy. Long-term management of patients with moderate to severe disease can include medications from the following classes: tumor necrosis factor (TNF)-alpha antagonists, immunomodulators (e.g., thiopurines [azathioprine], methotrexate), the anti-integrin agent vedolizumab (Entyvio®), and Janus kinase (JAK) inhibitors (e.g., tofacitinib [Xeljanz®]). If the agent selected for inducing remission is effective, it is usually continued as maintenance therapy. The exception to this would be when corticosteroids or cyclosporine are used for induction of remission. The following agents, listed in alphabetical order, are recommended over no treatment for adult outpatients with moderate to severe UC: adalimumab (Humira®), golimumab (Simponi®), infliximab (Remicade®), tofacitinib, ustekinumab (Stelara®), or vedolizumab (recommendation strength: strong; quality of evidence: moderate). In patients who are biologic-naïve, infliximab or vedolizumab are suggested rather than adalimumab for induction of remission (conditional; moderate); however, patients with less severe disease who value self-administration over efficacy of therapy may select adalimumab instead. For induction of remission, AGA suggests against thiopurine monotherapy (conditional; very low), but this is suggested over no treatment for maintaining remission (conditional; low). Methotrexate monotherapy is not suggested for induction or for maintenance of remission (conditional; low). The combination of a TNF-alpha antagonist, vedolizumab, or ustekinumab is suggested with a thiopurine or methotrexate over biologic monotherapy or thiopurine monotherapy (conditional; low). Notably, early use of biologics with or without immunomodulator therapy is suggested over gradual step up to these agents following failure of 5-aminosalicylates (5-ASA) (conditional; very low). For patients who achieve remission with biologic agents and/or immunomodulators or tofacitinib, the panel suggests against continuing 5-ASA for induction and maintenance of remission (conditional; very low). 3 | APRIL 2020

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Additional recommendations for adult outpatients with moderate to severe UC are provided in the guidance on the use of tofacitinib and management of nonresponders to infliximab.

COVID-19: NOTABLE DEVELOPMENTS The American Medical Association (AMA), American Pharmacists Association (APhA), and American Society of Health-System Pharmacists (ASHP) issued a joint statement on March 25, 2020 strongly advising against prophylactic prescribing of medications currently identified as potential treatments for COVID-19 (e.g., chloroquine, hydroxychloroquine, azithromycin). In addition, some healthcare providers (HCPs) have been prophylactically prescribing these medications for themselves, family members, or coworkers. These actions are strongly opposed by the groups. The AMA, APhA, and ASHP also oppose pharmacies and hospitals ordering excessive amounts of these medications for the potential use to treat or prevent COVID-19 infection. Stockpiling of these medications can lead to serious consequences for patients with conditions (e.g., lupus, rheumatoid arthritis) who require use of some of these medications on a regular basis. The organizations urge the healthcare community to collectively balance the limited resources between the needs of patients with chronic conditions currently using these medications and new prescriptions that may be needed for patients diagnosed with COVID-19. The FDA is addressing potential supply chain issues, including disruptions of critical drugs and medical devices. According to the FDA as of February 27, 2020, there is an unnamed drug shortage directly impacted by COVID-19, however, this drug has alternatives. Moreover, they have identified about 20 other unnamed, non-critical drugs, that are not in shortage but sourced from China. The FDA is working with manufacturers to mitigate shortages and continues to monitor the supply chain. For more information on COVID-19, visit the Magellan Rx Coronavirus (COVID-19) Update webpage. For the most current information, visit the FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO). State and local health departments also provide valuable information regarding management in local communities.


BEHAVIORAL HEALTH

CORNER FDA DRUG SAFETY COMMUNICATION: MONTELUKAST (SINGULAIR®) The FDA has recommended a boxed warning be added to the prescribing information for montelukast due to the potential for serious behavior and mood-related changes, including the potential for suicidal ideation or behavior. Montelukast is a leukotriene receptor antagonist indicated for prevention and chronic treatment of asthma in patients ≥ 12 months of age, acute prevention of exerciseinduced bronchoconstriction (EIB) in patients ≥ 5 years of age, relief of symptoms of seasonal allergic rhinitis in patients ≥ 2 years of age, and relief of symptoms of perennial allergic rhinitis in patients ≥ 6 months of age. Product labeling for all montelukast products already included a warning regarding the potential for neuropsychiatric events, as these have been reported in adult, adolescent, and pediatric patients. A number of post-marketing adverse events are described, including agitation, aggressive behavior, anxious feelings, depression, disorientation, changes in attention, dream abnormalities, stuttering, hallucinations, insomnia, memory impairment, and suicidal ideation/behavior. Although product labeling detailed these serious side effects and alerted patients and prescribers of these risks, the FDA has determined a

4 | APRIL 2020

stronger warning is warranted. In addition to the boxed warning, the FDA is requiring a new patient Medication Guide providing details on these risks. The FDA has previously provided communications regarding the mental health side effects with montelukast in 2008 and 2009. Data from the FDA’s Sentinel System and from the FDA’s Adverse Event Reporting System (FAERS) database was utilized to assess the risk for these events. This data, in conjunction with published observational and animal studies and an outside panel of experts, was used to further evaluate the potential for these side effects. Overall, new data regarding these risks are minimal; however, the reports received by the FDA for these events are ongoing. Furthermore, there are alternative agents for managing the conditions for which montelukast is used. As a result, the FDA reassessed the benefits versus risks of the drug and concluded a boxed warning was necessary. Notably, the agency is recommending montelukast only be used for allergic rhinitis when other allergy medications are not tolerated or do not provide adequate symptom control. In asthma patients, prescribers should evaluate the benefits versus risks of montelukast prior to prescribing.


BIOSIMILAR CORNER FDA LAUNCHES SEARCHABLE PURPLE BOOK The FDA has announced the launch of the first phase of the new Purple Book searchable database. The Purple Book is a reference source for information regarding FDA-approved biological products, including which products have received biosimilar and/or interchangeable designations. The new searchable database will eventually replace the current portable document format (PDF) lists for identifying FDA-approved biologic and biosimilar products. The new digital format of the Purple Book will enhance accessibility and transparency. A Federal Register notice along with a public comment open docket will be used to determine the next phases of the Purple Book’s development. The PDF lists will continue to be available until the searchable database is complete. The initial database version currently includes all approved biosimilar products and their related reference products. Once complete, the searchable database will contain all licensed biological products, including biological products transitioned from a new drug application (NDA) to a biologics license application (BLA) as required by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

5 | APRIL 2020

FDA AND FTC ISSUE STATEMENT SUPPORTING BIOSIMILAR ADOPTION The FDA and Federal Trade Commission (FTC) have issued a joint statement on efforts and steps that are going to be taken to prevent anti-competitive business practices for biologic products. Biosimilar and interchangeable products have the potential to substantially decrease healthcare costs; however, certain anti-competitive practices may be contributing to their slow adoption. The FDA and FTC have established 4 goals to support biosimilar adoption. The agencies will collaborate on the following: 1) enhance biologic product competition, including the FDA’s development of educational materials for consumers and prescribers regarding biosimilars; 2) ensure biosimilar developers have access to samples of the reference product for conducting tests assessing biosimilarity and/or interchangeability; 3) mitigate false or misleading claims regarding biologics, including biosimilars; and 4) evaluate patent settlement arrangements between reference product and biosimilar manufacturers for anticompetitive practices and antitrust violations.


DRUG INFORMATION

HIGHLIGHTS • F  or the week ending March 28, 2020, the CDC reported that laboratory-confirmed influenza has continued to decrease sharply and is now considered to be low; however, influenza-like illness (ILI) activity is still elevated. The proportion of patients utilizing healthcare may be impacted by the COVID-19 pandemic. Puerto Rico and 22 states reported widespread influenza activity, and the remaining areas reported regional, local, or sporadic influenza activity. Nationwide, influenza A(H1N1)pdm09 is the predominant virus. No widespread shortages of antivirals used to treat influenza have been reported. • Brand Epipen®, Epipen Jr®, and authorized generic (AG) versions of the epinephrine auto-injectors may have improper injection that could delay or prevent emergency treatment. The device may activate prematurely if the blue safety release is raised or is removed using a sideway force. The carrier tube rim of some devices may be deformed preventing ease of device removal from the tube. Additionally, user errors may impede proper and timely delivery of the medication. Pharmacists should inspect the product before dispensing to ensure the blue safety release is not raised and that the device can be easily removed from the carrier tube. Patients should perform a similar inspection and periodically review the instructions for use prior to needing the medication. Patients may obtain replacement of affected product at no additional cost by contacting Mylan Customer Relations. • T he FDA is reporting shortages of epinephrine autoinjectors. Mylan Specialty is reporting manufacturing delays of Epipen 0.3 mg, Epipen Jr 0.15 mg, and AG versions. Supplies will vary among pharmacies. Teva is experiencing sporadic supply interruptions of their generic epinephrine 0.3 mg and 0.15 mg auto-injectors. Supply of both strengths of Impax’s generic version are on allocation due to manufacturing delays. All strengths of Kaleo’s Auvi-Q® and Adamis’s Symjepi® are available.

6 | APRIL 2020

• T he FDA has approved prescription to over-the-counter (OTC) switches for 1 topical product and 2 ophthalmic products. Diclofenac sodium topical gel, 1% (Voltaren® Gel) will now be available OTC as Voltaren Arthritis Pain starting in Spring 2020. It is approved for the temporary relief of arthritis pain. Two OTC formulations of olopatadine hydrochloride have also received FDA approval: Pataday® Twice Daily Relief (0.1%; formerly Patanol Rx version) and Pataday® Once Daily Relief (0.2%; formerly Pataday Rx version). The Pataday products are approved for the temporary relief of itchy eyes due to various allergens. The prescription versions of all 3 products will be discontinued. • T aro has issued a voluntary recall of 2 lots of phenytoin oral suspension, USP in the strength of 125 mg/5 mL in 237 mL bottles. Product from these lots may not resuspend properly upon being shaken, which is a required step in the administration process. Failure of the drug to properly resuspend could potentially lead to over- or under-dosing of the anti-seizure medication. • A  merican Health Packaging (AHP) has issued a voluntary recall of 11 lots of ranitidine tablets, USP 150 mg supplied as 100-count unit-dose blister packs due to the potential for N-nitrosodimethylamine (NDMA) levels higher than allowed by the FDA. This is an extension of the recall by Amneal that included impacted lots which were repackaged by AHP. • Hikma (formerly known as West-Ward) is voluntarily extending its previously announced recall of certain lots of the non-steroidal anti-inflammatory drug (NSAID) ketorolac tromethamine injection USP 30 mg/mL, 1 mL fill/2 mL vials to the medical facility and retail levels. The recall is due to the presence of small visible particulate matter of a gelatinous/oily nature that appear black in some lots and have the potential to cause particulate deposition in the lung, pulmonary microemboli, and acute respiratory distress. No adverse events have been reported to date.


PIPELINE

NEWS

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

FORMULATION THERAPEUTIC CLASS

PROPOSED CLINICAL USE

ANTICIPATED FDA APPROVAL

encorafenib (Braftovi®) Pfizer

• Oral • BRAF kinase inhibitor

Colorectal cancer (advanced BRAF V600E-mutant metastatic disease, in combination with cetuximab ± binimetinib, after 1 to 2 prior therapies)

April 2020

satralizumab Genentech

• SC • Interleukin-23 (IL-23) inhibitor

Neuromyelitis optica (Devic’s syndrome)

Apr–May 2020

olaparib (Lynparza®) AstraZeneca

• Oral • Poly (ADP-ribose) polymerase (PARP) inhibitor

Prostate cancer (metastatic castration-resistant)

Apr–Jun 2020

selumetinib AstraZeneca

• Oral • Mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor

Neurofibromatosis

Apr–Jun 2020

mitomycin Urogen

• Intravesical •Cytotoxic agent (DNA synthesis

Bladder cancer

04/17/2020

Men Quad TT Sanofi

• IM • Meningitis B vaccine

Meningococcal meningitis prevention

04/24/2020

opicapone Neurocrine Biosciences

• Oral • Catechol-Omethyltransferase (COMT) inhibitor

Parkinson’s disease (off-episodes)

04/24/2020

treprostinil patch pump United Therapeutics

• SC • Prostaglandin vasodilator

Pulmonary arterial hypertension

04/27/2020

padeliporfin di-potassium Steba Biotech

• IV • Photosensitizer

Prostate cancer (localized)

05/01/2020

IM = intramuscular; IV = intravenous; SC = subcutaneous

7 | APRIL 2020


RECENT FDA

APPROVALS DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs amisulpride (Barhemsys®) Arcacia

• 505(b)(2) NDA approval 02/26/2020 • Indicated for use in adults for: » prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class » treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis • Dopamine-2 (D2) antagonist • Injection: 5 mg/2 mL solution in a single-dose vial (SDV) • Recommended dosage for: » prevention of PONV is 5 mg as a single IV dose administered over 1 to 2 minutes at the time of induction of anesthesia » treatment of PONV is 10 mg as a single IV dose over 1 to 2 minutes in the event of nausea/vomiting after a surgical procedure • Product availability is expected in 2H 2020

rimegepant (Nurtec™ ODT) Biohaven

• NDA approval 02/27/2020 • Indicated for the acute treatment of migraine with or without aura in adults; it is not indicated for the preventive treatment of migraine • Calcitonin gene-related peptide receptor (CGRP) inhibitor • Orally disintegrating tablet (ODT): 75 mg in packs of 8 tablets • Recommended dosage is 75 mg taken orally, as needed; the maximum dosage is 75 mg in a 24-hour period; safety has not been established for treating > 15 migraines in a 30-day period

ibuprofen/ acetaminophen (Advil® Dual Action with Acetaminophen) Pfizer

• 505(b)(2) NDA approval 02/28/2020; OTC • Indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and arthritis • NSAID/analgesic • Fixed-dose tablet: 125 mg ibuprofen/250 mg acetaminophen • Recommended dosage in adults and children ages ≥ 12 years is 2 tablets orally every 8 hours while symptoms persist; do not exceed 6 tablets in 24 hours, unless directed by a physician; consult a physician for use in children ages < 12 years • Product availability is expected in 2020

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 | APRIL 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs continued isatuximab-irfc (Sarclisa®) Sanofi

• BLA approval 03/02/2020; Orphan Drug • Indicated for use in combination with pomalidomide and dexamethasone, to treat adults with multiple myeloma who have received ≥ 2 prior therapies including lenalidomide and a proteasome inhibitor • CD38-directed cytolytic antibody • Injection: 20 mg/mL solution in 5 mL and 25 mL SDVs • Recommended dosage is 10 mg/kg administered as an IV infusion every week for 4 weeks, then every 2 weeks in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity » Premedicate with dexamethasone, acetaminophen, a histamine-2 (H2) antagonist, and diphenhydramine » Administer in a setting that can provide emergency medical support to manage infusion-related reactions

bimatoprost intracameral implant (Durysta™) Allergan

• NDA approval 03/04/2020 • Indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) • Prostaglandin analog • Biodegradable intracameral implant: 10 mcg • Recommended dosage is 1 implant injected under aseptic conditions by a HCP into the anterior chamber of the eye; an implant should not be readministered to an eye that had previously received the implant • Product availability is expected 2Q 2020

osilodrostat (Isturisa®) Novartis

• NDA approval 03/06/2020; Orphan Drug • Indicated for the treatment of Cushing’s disease in adults for whom pituitary surgery is not an option or has not been curative • Cortisol synthesis inhibitor • Tablets: 1 mg, 5 mg, and 10 mg • Recommended initial dosage is 2 mg orally twice daily with or without food; titrate by 1 to 2 mg twice daily, no more frequently than every 2 weeks, based on rate of cortisol changes, patient tolerability, and symptom improvement; maximum dosage is 30 mg twice daily • Product availability is expected in 2Q to 3Q 2020

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.

9 | APRIL 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs continued romidepsin (no trade name) Teva

• 505(b)(2) NDA approval 03/13/2020; Accelerated Approval • Indicated for the treatment of adults with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) who have received ≥ 1 prior therapy for either condition; continued approval for PTCL may depend on results from confirmatory trials • Histone deacetylase (HDAC) inhibitor • Injection: 5 mg/mL solution in 2 mL and 5.5 mL in SDVs • Recommended dosage is 14 mg/m2 IV over 4 hours on days 1, 8, and 15 of a 28-day cycle; repeat cycle every 28 days based on continued benefit and tolerability • Romidepsin lyophilized powder for reconstitution is available under the brand name Istodax® with the same indications and recommended dosage as romidepsin solution

Expanded Indications neratinib (Nerlynx®) Puma

• sNDA approval 02/25/2020 • New indication for use in combination with capecitabine for the treatment of adults with advanced or metastatic human epidermal growth factor receptor 2 (HER2)positive breast cancer who have received ≥ 2 prior anti-HER2-based regimens in the metastatic setting » Also indicated as monotherapy for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumabbased therapy • Recommended dosage is 240 mg orally once daily with food on days 1 through 21 of a 21-day cycle plus capecitabine 750 mg/m2 orally twice daily on days 1 through 14 of a 21-day cycle; repeat 21-day cycle until disease progression or unacceptable toxicity

cobicistat/darunavir/ emtricitabine/tenofovir alafenamide (Symtuza®) Janssen

• sNDA approval 03/02/2020 • Expanded indication to include use as a complete regimen for the treatment of human immunodeficiency-1 (HIV-1) infection in pediatric patients weighing ≥ 40 kg who have had no prior antiretroviral (ARV) treatment history or who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable ARV regimen for ≥ 6 months and have no known substitutions associated with resistance to darunavir or tenofovir » Previously indicated only for adult patients who met this criteria • Recommended dosage is 1 tablet orally once daily with food in adults and pediatric patients weighing ≥ 40 kg

nintedanib (Ofev®) Boehringer Ingelheim

• sNDA approval 03/09/2020; Breakthrough Therapy, Priority Review • New indication for the treatment for chronic fibrosing interstitial lung diseases with a progressive phenotype » Also indicated to treat idiopathic pulmonary fibrosis and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease • Recommended dosage is 150 mg twice daily (~12 hours apart)

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 | APRIL 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

Expanded Indications continued talazoparib (Talzenna®) Pfizer

• sNDA approval 03/09/2020 • Expanded indication for the treatment of adults with deleterious or suspected deleterious germline breast cancer susceptibility gene-mutated (gBRCAm) HER2negative locally advanced or metastatic breast cancer to include use in patients with severe renal impairment (creatinine clearance [CrCl], 15 to 29 mL/min) • Recommended dosage in this population is 0.5 mg orally once daily

nivolumab (Opdivo®) + ipilimumab (Yervoy®) Bristol-Myers Squibb

• sBLA approval 03/10/2020; Accelerated Approval • New indication for the use of nivolumab in combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; continued approval may depend on confirmatory trial results » Nivolumab is also indicated for use as a single agent in patients with HCC previously treated with sorafenib • Recommended dosage is nivolumab 1 mg/kg IV every 3 weeks and ipilimumab 3 mg/kg IV administered on the same day; after completing 4 combination doses, continue nivolumab at 240 mg every 2 weeks or 480 mg every 4 weeks until disease progression or unacceptable toxicity

sofosbuvir/velpatasvir (Epclusa®) Gilead

• sNDA approval 03/19/2020; Priority Review • Expanded indication to include use in patients as young as 6 years or weighing ≥ 17 kg for the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis or with decompensated cirrhosis for use in combination with ribavirin » Previously only approved for use in adults • Recommended dosage in pediatrics is weight-based (daily dose of 200 mg/50 mg or 400 mg/100 mg as described in the prescribing information) • The FDA also approved a 200 mg/50 mg tablet to accommodate pediatric dosing

crisaborole (Eucrisa™) Pfizer

• sNDA approval 03/23/2020 • Expanded indication to include use in patients 3 months to < 2 years of age for the topical treatment of mild to moderate atopic dermatitis » Previously only approved in patients ages ≥ 2 years •Recommended dosage for all ages is application of a thin layer of the ointment to affected areas twice daily

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: ashp.org

cdc.gov

11 | APRIL 2020

fda.gov

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MRx Clinical Alert - April 2020  

MRx Clinical Alert - April 2020