Your Monthly Source for Drug Information Highlights
EDITORIAL STAFF
EDITOR-IN-CHIEF
Maryam Tabatabai
PharmD
INTERIM EXECUTIVE EDITOR
Olivia Pane
PharmD, CDCES
DEPUTY EDITORS
Jessica Czechowski
PharmD
Carole Kerzic
RPh
Devon Trumbower
PharmD, BCPS
WEIGHT MANAGEMENT CORNER
BIOSIMILAR NOTABLES
BEHAVIORAL HEALTH UPDATES
DRUG INFORMATION HAPPENINGS & HIGHLIGHTS
PIPELINE NEWS
RECENT FDA APPROVALS
The FDA has approved beremagene geperpavec-svdt (Vyjuvek™), an HSV-1 vector-based gene therapy, for treatment of wounds in patients ≥ 6 months of age with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. Vyjuvek works by increasing production and secretion of the COL7 protein, resulting in improved wound healing. The product is available as a 5 x 109 PFU/mL biological suspension in a single-use vial, which is mixed into an excipient gel prior to administration. Vyjuvek is applied topically to the wound(s) once weekly by an HCP until wound closure. The recommended dosage per wound ranges from 4 x 108 PFU (0.2 mL) to 1.2 x 109 PFU (0.6 mL) depending on wound size. The maximum weekly dosage is 1.6 x 109 PFU (0.8 mL) for patients ages 6 months to < 3 years and 3.2 x 109 PFU (1.6 mL) for patients ≥ 3 years of age. Application to all wounds may not be possible at each treatment visit, and treatment should continue until wound closure before new wounds are selected for treatment. Previously treated wounds that have re-opened should be prioritized. Vyjuvek carries a warning for accidental exposure; though the drug will not replicate or integrate into the genetic material of the subject’s cells, HCPs should follow universal biohazard precautions when handling the medication.
The efficacy and safety of Vyjuvek were evaluated in an intra-patient randomized, double-blind, placebocontrolled trial, which included 31 patients with DEB. All study participants were ≥ 6 months of age with clinical manifestations of DEB and genetically confirmed COL7A1 gene mutation(s). The age of study participants ranged from 1 year to 44 years (mean 17 years), and the size of treated wounds ranged from 2 cm2 to 57 cm2. Two wounds were identified in each subject; one wound was treated with topical Vyjuvek gel and the other was treated with placebo once weekly for 26 weeks. The primary efficacy endpoint was the difference in proportion of complete (100%) wound closure after 6 months of treatment, confirmed at 2 consecutive visits 2 weeks apart. After 6 months, 67% of wounds had completely closed with Vyjuvek therapy compared to 22% of those treated with placebo, for a treatment difference of 46% (95% CI, 24% to 68%, p=0.002).
An FDA Drug Safety Communication has been released regarding ADR reports with use of compounded semaglutide products that may not contain the same active ingredient as FDA-approved semaglutide (Ozempic®, Rybelsus® , Wegovy®) and instead may contain salt formulations (e.g., semaglutide sodium, semaglutide acetate). The agency recommends patients avoid compounded semaglutide if an approved drug is available. Novo Nordisk issued a notice regarding the sale of a counterfeit semaglutide (Ozempic) pen containing insulin glargine. It is recommended that pharmacies purchase product through an authorized distributor and that patients check the product label prior to use.
Adalimumab-aaty (Yuflyma®), a biosimilar to adalimumab (Humira®), has been approved for treatment of RA, JIA, PsA, AS, CD, UC, PsO, and HS. The product will be available as a high-concentration, citrate-free 40 mg/0.4 mL singledose prefilled autoinjector and syringe. The FDA has approved a new 40 mg/0.8 mL single-dose prefilled autoinjector pen presentation for the interchangeable Humira biosimilar adalimumab-adbm (Cyltezo®).
The first nalmefene nasal spray, Opvee®, received approval for emergency treatment of known or suspected overdose induced by natural or synthetic opioids in patients ≥ 12 years of age, as manifested by respiratory and/or CNS depression. Opvee spray contains nalmefene 2.7 mg (0.1 mL). The recommended dosage is 1 spray intranasally with additional doses given every 2 to 5 minutes, if needed, until emergency assistance arrives. An ER buprenorphine injection, Brixadi™, has been approved for treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of transmucosal buprenorphine or who are already being treated with buprenorphine. This SC injection is administered by an HCP weekly or monthly, with dosage and frequency depending on prior buprenorphine treatment. Brixadi is a CIII controlled substance and requires REMS certification. Escitalopram’s (Lexapro®) indication for GAD has been expanded to include patients 7 to 17 years of age. The initial dose for pediatric patients for GAD is 10 mg orally once daily, with a maximum dose of 20 mg daily.
• Abbvie has voluntarily withdrawn Accelerated Approval of ibrutinib (Imbruvica®) for treatment of adults with mantle cell lymphoma who have received ≥ 1 prior therapy and for treatment of adults with marginal zone lymphoma who require systemic therapy and have received ≥ 1 prior anti-CD20-based therapy. Its other FDA-approved indications remain unchanged. The 560 mg tablet has been discontinued
• Upadacitinib ( Rinvoq ®) has received approval for treatment of moderately to severely active CD in adults who have had an inadequate response or intolerance to ≥ 1 TNF blocker(s), making it the first oral therapy available for treatment of moderate to severe CD. After an induction dosage of 45 mg orally once daily for 12 weeks, the recommended maintenance dose is 15 mg orally once daily. A maintenance dose of 30 mg once daily can be considered for refractory, severe, or extensive CD.
• GlaxoSmithKline will discontinue distribution of the following fluticasone propionate inhalational powder products: Flovent® HFA 44 mcg, 110 mcg, and 220 mcg; and Flovent® Diskus® 50 mcg, 100 mcg, and 250 mcg. The last date for product ordering will be December 31, 2023.
• The indication for maintenance treatment of asthma for fluticasone furoate/vilanterol ( Breo ® Ellipta ®) 100/25 mcg has been expanded to include patients 12 to 17 years of age. A new 50/25 mcg strength of the product has been approved for maintenance treatment of asthma in patients 5 to 11 years of age. The recommended dose for all ages and presentations is 1 actuation once daily via oral inhalation.
• The FDA and SAMHSA have issued a letter which discusses buprenorphine prescribing recommendations. A separate waiver is no longer required to dispense buprenorphine, and prescribing of buprenorphine should not be contingent upon patient participation in counseling or other services (e.g., case management, peer support), though these should be offered.
• The FDA has approved an expanded indication for dapagliflozin (Farxiga®) to reduce the risk of CV death, hospitalization for HF, and urgent HF visits in adults with HF. The HF indication is no longer limited to those with HFrEF (NYHA class II to IV). The recommended starting dose for this expanded indication is 10 mg orally once daily.
• The FDA has revoked the EUA for the Janssen COVID-19 vaccine after a request for voluntary withdrawal from the manufacturer.
• The agency has released its annual Drug Shortages Report to Congress, which summarizes actions taken to prevent or mitigate drug shortages in 2022.
• The FDA has alerted consumers that there are no approved products on the market for treatment of molluscum (water warts). The agency advises against the use of products that claim to treat molluscum.
• ICER issued a final evidence report on the use of resmetirom and obeticholic acid for NASH. Resmetirom has adequate evidence demonstrating benefit in stage 2 and 3 fibrosis, while obeticholic acid has insufficient evidence in stage 2 fibrosis and promising but inconclusive evidence for stage 3 fibrosis.
• An FDA Advisory Committee voted unanimously that lecanemab (Leqembi™) shows clinical benefit for the treatment of Alzheimer’s disease.
• CMS has announced that Medicare Part B will cover medications that slow Alzheimer’s disease progression if (1) the drug is granted traditional FDA approval, (2) the patient is diagnosed with mild cognitive impairment or early dementia due to Alzheimer’s disease, and (3) the patient is followed by a qualified physician participating in a registry and has appropriate follow-up care.
cipaglucosidase alfa Amicus
nirsevimab AstraZeneca/Sanofi
sofpironium Botanix
etrasimod Pfizer
ustekinumab (biosimilar to Janssen’s Stelara®) Alvotech
cantharidin Verrica
quizartinib
Daiichi Sankyo
risperidone (once monthly)
Laboratorios
Farmacéuticos Rovi
• IV
• Enzyme replacement therapy
• IM
• Antiviral antibody
Pompe disease (in combination with oral miglustat)
RSV prevention (newborns and infants in 1st RSV season; at risk patients ages ≤ 24 months through 2nd RSV season)
• Anticholinergic Axillary hyperhidrosis (severe)
• Topical
• Oral
• S1P receptor modulator
• SC
• IL-12/IL-23 antagonist
• Topical
• Blistering agent
• Oral
• Tyrosine kinase receptor inhibitor
• IM
• Atypical antipsychotic
UC (moderate to severe)
PSO; PsA; CD; UC
AML (in combination with cytarabine and/or anthracycline induction and consolidation, and monotherapy following consolidation)
sotagliflozin (Inpefa™)
Lexicon
cyclosporine (Vevye™)
Novaliq
respiratory syncytial virus vaccine (Abrysvo™) Pfizer
glofitamab-gxbm (Columvi™) Genentech
• NDA approval 05/26/2023; Standard Review
• Indicated for adults with HF or T2DM, CKD, and other CV risk factors to reduce the risk of CV death, hospitalization for HF, and urgent HF visit
• Sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibitor
• Oral tablet: 200 mg, 400 mg
• Recommended initial dosage is 200 mg orally once daily not > 1 hour before the first meal of the day, titrated after ≥ 2 weeks to 400 mg once daily
• Product availability is expected by the end of June 2023
• 505(b)(2) NDA approval 05/30/2023; Standard Review
• Indicated to treat the signs and symptoms of dry eye disease in adults
• Calcineurin inhibitor immunosuppressant
• Preservative-free ophthalmic solution: 0.1%
• Recommended dosage is 1 drop in each eye twice daily approximately 12 hours apart and separated from other eye drops by a 15-minute interval
• BLA approval 05/31/2023; Breakthrough Therapy, Priority Review
• Indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥ 60 years of age
• Recombinant protein vaccine
• Lyophilized antigen component requires dilution with accompanying sterile water diluent in a prefilled syringe
• Recommended dosage is a single 0.5 mL IM dose
• Product availability is expected by Q3 2023
• BLA approval 06/15/2023; Accelerated Approval, Fast Track, Priority Review
• Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after ≥ 2 lines of systemic therapy; continued approval for this use may require demonstration of benefit in confirmatory clinical trials
• Bispecific CD20-directed CD3 T-cell engager
• Single-dose vial: 2.5 mg/2.5 mL, 10 mg/10 mL
• HCP-administered IV infusion with step-up dosing on days 8 and 15 of cycle 1 (following day 1 pretreatment with obinutuzumab [Gazyva®]), then administered on day 1 of subsequent 21-day cycles for a maximum of 12 cycles or until disease progression or unacceptable toxicity
• Labeled with a boxed warning related to the risk of cytokine release syndrome
• Product availability is expected in Q3 2023
polyethylene glycol
3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution (Suflave®)
Braintree Labs
• NDA approval 06/15/2023; Standard Review
• Indicated for cleansing of the colon in preparation for colonoscopy in adults
• Osmotic laxative
• Recommended dosage is 1 liter of reconstituted solution (with a flavor-enhancing packet) early in the evening prior to colonoscopy and 1 liter of reconstituted solution (with a flavor-enhancing packet) 5 to 8 hours prior to colonoscopy; each dose should be consumed as 8 ounces every 15 minutes and followed by 16 ounces of water
505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.
Glossary:
ADR adverse drug reaction
AML acute myeloid leukemia
AS ankylosing spondylitis
BLA Biologics License Application
CD Crohn’s disease
CD20 cluster of differentiation 20
CD3 cluster of differentiation 3
CI confidence interval
CKD chronic kidney disease
CMS Centers for Medicare & Medicaid Services
CNS central nervous system
COL7 collagen type VII
COVID-19 Coronavirus Disease 2019
CV cardiovascular
DEB dystrophic epidermolysis bullosa
ER extended-release
EUA emergency use authorization
FDA Food and Drug Administration
References:
cdc.gov fda.gov cms.gov icer.org nejm.org
GAD generalized anxiety disorder
HCP healthcare professional
HF heart failure
HFA hydrofluoroalkane
HFrEF heart failure with reduced ejection fraction
HS hidradenitis suppurativa
HSV-1 herpes-simplex virus type 1
ICER Institute for Clinical and Economic Review
IL-12 interleukin 12
IL-17 interleukin 17
IL-23 interleukin 23
IM intramuscular
IV intravenous
JIA juvenile idiopathic arthritis
NASH non-alcoholic steatohepatitis
NDA New Drug Application
NYHA New York Heart Association
PFU plaque forming units
PsA psoriatic arthritis
PsO plaque psoriasis
Q quarter
RA rheumatoid arthritis
REMS Risk Evaluation and Mitigation Strategies
RSV respiratory syncytial virus
S1P sphingosine-1-phosphate
SAMHSA Substance Abuse and Mental Health Services Administration
SC subcutaneous
T2DM type 2 diabetes mellitus
TNF tumor necrosis factor
UC ulcerative colitis
Disclaimer: The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your healthcare provider.
© 2023. Magellan Rx Management, a Prime Therapeutics LLC company. All rights reserved.