APRIL 2020

CLINICAL
ALERT
YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS

EDITORIAL STAFF

EDITOR IN CHIEF BEHAVIORAL

Maryam Tabatabai TRENDING BIOSIMILAR
HEALTH
PharmD TOPICS CORNER
CORNER
EXECUTIVE EDITOR
Carole Kerzic
RPh

DEPUTY EDITORS
Jessica Czechowski
PharmD
DRUG RECENT
INFORMATION PIPELINE
Lara Frick FDA
PharmD, BCPS, BCPP
HIGHLIGHTS NEWS
APPROVALS
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 fixed-
dose 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, placebo-
controlled 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 non-
responders 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 exercise-
induced 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 auto-
injectors. 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 FORMULATION ANTICIPATED
PROPOSED CLINICAL USE
MANUFACTURER THERAPEUTIC CLASS FDA APPROVAL

encorafenib (Braftovi®) • Oral Colorectal cancer (advanced BRAF April 2020

Pfizer • BRAF kinase inhibitor V600E-mutant metastatic disease,
in combination with cetuximab
± binimetinib, after 1 to 2 prior
therapies)

satralizumab • SC Neuromyelitis optica (Devic’s Apr–May 2020

Genentech • Interleukin-23 (IL-23) syndrome)
inhibitor

olaparib (Lynparza®) • Oral Prostate cancer (metastatic Apr–Jun 2020

AstraZeneca • Poly (ADP-ribose) castration-resistant)
polymerase (PARP)
inhibitor

selumetinib • Oral Neurofibromatosis Apr–Jun 2020

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

mitomycin • Intravesical Bladder cancer 04/17/2020

Urogen •Cytotoxic agent (DNA
synthesis

Men Quad TT • IM Meningococcal meningitis prevention 04/24/2020

Sanofi • Meningitis B vaccine

opicapone • Oral Parkinson’s disease (off-episodes) 04/24/2020

Neurocrine Biosciences • Catechol-O-
methyltransferase
(COMT) inhibitor

treprostinil patch pump • SC Pulmonary arterial hypertension 04/27/2020

United Therapeutics • Prostaglandin
vasodilator

padeliporfin di-potassium • IV Prostate cancer (localized) 05/01/2020

Steba Biotech • Photosensitizer
IM = intramuscular; IV = intravenous; SC = subcutaneous

7 | APRIL 2020
 RECENT FDA
APPROVALS
DRUG NAME
DESCRIPTION
MANUFACTURER

New Drugs

amisulpride • 505(b)(2) NDA approval 02/26/2020

(Barhemsys®) • Indicated for use in adults for:
Arcacia » 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 • NDA approval 02/27/2020

(Nurtec™ ODT) • Indicated for the acute treatment of migraine with or without aura in adults; it is not
Biohaven 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/ • 505(b)(2) NDA approval 02/28/2020; OTC

acetaminophen • Indicated for the temporary relief of minor aches and pains due to headache,
(Advil® Dual Action with backache, muscular aches, toothache, menstrual cramps, and arthritis
Acetaminophen) • NSAID/analgesic
Pfizer • 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
DESCRIPTION
MANUFACTURER

New Drugs continued

isatuximab-irfc • BLA approval 03/02/2020; Orphan Drug

(Sarclisa®) • Indicated for use in combination with pomalidomide and dexamethasone, to treat
Sanofi 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 • NDA approval 03/04/2020

intracameral implant • Indicated for the reduction of intraocular pressure (IOP) in patients with open angle
(Durysta™) glaucoma (OAG) or ocular hypertension (OHT)
Allergan • 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 • NDA approval 03/06/2020; Orphan Drug

(Isturisa®) • Indicated for the treatment of Cushing’s disease in adults for whom pituitary surgery
Novartis 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
DESCRIPTION
MANUFACTURER

New Drugs continued

romidepsin • 505(b)(2) NDA approval 03/13/2020; Accelerated Approval

(no trade name) • Indicated for the treatment of adults with cutaneous T-cell lymphoma (CTCL) or
Teva 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 • sNDA approval 02/25/2020

(Nerlynx®) • New indication for use in combination with capecitabine for the treatment of adults
Puma 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 trastuzumab-
based 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/ • sNDA approval 03/02/2020

emtricitabine/tenofovir • Expanded indication to include use as a complete regimen for the treatment of
alafenamide human immunodeficiency-1 (HIV-1) infection in pediatric patients weighing ≥ 40 kg
(Symtuza®) who have had no prior antiretroviral (ARV) treatment history or who are virologically
Janssen 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 • sNDA approval 03/09/2020; Breakthrough Therapy, Priority Review

(Ofev®) • New indication for the treatment for chronic fibrosing interstitial lung diseases with
Boehringer Ingelheim 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
DESCRIPTION
MANUFACTURER

Expanded Indications continued

talazoparib • sNDA approval 03/09/2020

(Talzenna®) • Expanded indication for the treatment of adults with deleterious or suspected
Pfizer deleterious germline breast cancer susceptibility gene-mutated (gBRCAm) HER2-
negative 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 • sBLA approval 03/10/2020; Accelerated Approval

(Opdivo®) • New indication for the use of nivolumab in combination with ipilimumab, for the
+ treatment of patients with hepatocellular carcinoma (HCC) who have been previously
ipilimumab treated with sorafenib; continued approval may depend on confirmatory trial results
(Yervoy®) » Nivolumab is also indicated for use as a single agent in patients with HCC previously
Bristol-Myers Squibb 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 • sNDA approval 03/19/2020; Priority Review

(Epclusa®) • Expanded indication to include use in patients as young as 6 years or weighing
Gilead ≥ 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 • sNDA approval 03/23/2020

(Eucrisa™) • Expanded indication to include use in patients 3 months to < 2 years of age for the
Pfizer 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 fda.gov gastro.org

11 | APRIL 2020 © 2020, Magellan Health. All rights reserved.