ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS
EDITORIAL STAFF EDITOR-IN-CHIEF Maryam Tabatabai PharmD EXECUTIVE EDITOR Anna Schreck Bird PharmD
RECENT FDA APPROVALS
DEPUTY EDITORS Jessica Czechowski PharmD Carole Kerzic RPh Leslie Pittman PharmD
DRUG INFORMATION HAPPENINGS & HIGHLIGHTS
TRENDING TOPICS COVID-19 VACCINE UPDATE
RSV INTERIM GUIDANCE EXTENDED
The FDA has amended the EUAs for both the Moderna COVID-19 vaccine and the Pfizer-Biontech COVID-19 vaccine to include use for prevention of COVID-19 caused by SARS-CoV-2 in children ≥ 6 months of age. The amended Moderna EUA now includes use in those 6 months to 17 years old (previously authorized for use in those ≥ 18 years old), and the Pfizer-Biontech EUA now includes use in those 6 months to 4 years of age (previously authorized for use in those ≥ 5 years old). The FDA’s decision followed the VRBPAC’s unanimous vote in favor of EUAs for these pediatric ages. The CDC has also endorsed the ACIPs’ recommendation that all children 6 months to 5 years of age receive a COVID-19 vaccine.
The AAP’s COVID-19 clinical Interim Guidance for the use of palivizumab (Synagis®) for RSV has been extended. This interim guidance which was set to expire on June 30, 2022 will now expire on December 31, 2022, unless otherwise specified. RSV activity in the US remains variable by region. The interim guidance will be regularly reviewed with emerging evidence.
For the Moderna vaccine, the authorized dosing regimen for children 6 months to 17 years of age is a primary series of 2 doses administered 1 month apart; immunocompromised individuals can also receive an additional primary series dose (third dose) ≥ 1 month after the second dose. For the Pfizer-Biontech vaccine, the authorized dosing regimen for children 6 months through 4 years of age is a primary series of 3 doses with the first 2 doses separated by 3 weeks and a third dose given ≥ 8 weeks following the second dose. On a related note, the VRBPAC has voted in favor of EUA for the Novavax COVID-19 vaccine for individuals ≥ 18 years old. The protein-based vaccine is administered as two 0.5 mL doses comprised of 5 mcg of antigen and 50 mcg of Matrix-M™ adjuvant IM 21 days apart. Vials of vaccine contain ready-to-use liquid and are stored at 2° to 8° C. Based on the PREVENT-19 phase 3 clinical study conducted in adults, vaccine efficacy was 90.4% (95% confidence interval [CI], 82.9 to 94.6; p<0.001). Novavax has released a statement in response to the FDA’s Briefing Document that raised concerns of a causal relationship with the vaccine and cases of myocarditis/pericarditis, similar to what has been observed with mRNA vaccines.
2 | JULY 2022
COVID-19: NOTABLE DEVELOPMENTS The VRBPAC has voted in favor of including a SARS-CoV-2 Omicron component in COVID-19 vaccine booster doses, and the FDA has instructed manufacturers that are planning to update their vaccine to create a modified vaccine that adds an Omicron BA.4/5 component to the current composition, resulting in 2 component (bivalent) booster vaccines. The agency has released additional guidance for HCPs to assess potential drug interactions with ritonavir-boosted nirmatrelvir (Paxlovid™), including updates to the Prescriber Patient Eligibility Screening Checklist. The NIH has published a new section to their COVID-19 Treatment Guidelines that advises on drug interactions with Paxlovid and includes resources to identify potential interactions and strategies for managing certain interactions. The CDC also issued an official health advisory on rebound COVID-19 following Paxlovid treatment; currently, there is no evidence to demonstrate that additional treatment is required with Paxlovid or other therapies when COVID-19 rebound occurs, and it is not known if the potential for transmission during rebound differs from the potential for transmission during the initial phase of infection. The FDA has authorized the first OTC COVID-19 test that also detects influenza and RSV: Labcorp Seasonal Respiratory Virus RT-PCR DTC Test. Authorization marks the first non-prescription multianalyte COVID-19 test that allows for self-collection via a nasal swab sample at home followed by mailing of the sample to Labcorp for analysis. Please refer to the COVID-19 disclaimer at the end of the publication.
HAPPENINGS & HIGHLIGHTS • The FDA announced that the authorized generic NDCs of the diazepam rectal gel 10 mg and 2.5 mg syringe 2-packs are currently unavailable. Availability of the generic 10 mg syringe is anticipated in September 2022 and of the 2.5 mg syringe is TBD. A shortage of 20 mg rectal gel has not been reported. Bausch Health has no plans to manufacture brand Diastat® Rectal Gel (2.5 mg) and Diastat® AcuDial™ (10 mg and 20 mg); Diastat AcuDial 20 mg is in limited supply until July 2022. • The FDA has approved a shelf-life extension from 36 months to 48 months for the on-demand contraceptive Phexxi®, a combination of lactic acid, citric acid, and potassium bitartrate. • The agency has approved a new indication for baricitinib (Olumiant®) for the treatment of adults with severe alopecia areata. This is the first FDA approval for a systemic treatment for this autoimmune disorder that leads to hair loss. Baricitinib is a JAK inhibitor that is also indicated for certain patients with RA as well as COVID-19. For alopecia areata, the dose is 2 mg orally once daily and may be increased to 4 mg daily.
• Two new strengths of lumateperone (Caplyta®) have been approved: 10.5 mg and 21 mg capsules; it was already approved as a 42 mg capsule. The new dosage strengths allow for dose adjustments for hepatic impairment and drug interactions. The new strengths will be available in mid-2022. • Clovis Oncology has voluntarily withdrawn the indication of rucaparib (Rubraca®) for monotherapy in patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer after ≥ 2 chemotherapies. This indication was approved under an Accelerated Approval in 2016. Withdrawal is based on the ARIEL-4 overall survival data. Other FDA-approved indications for rucaparib remain. • Teva has voluntarily recalled a single lot (lot GD01090; expiration 05/2022) of Anagrelide Capsules, USP 0.5 mg (NDC 0172-5241-60) to the consumer level due to dissolution test failure found during routine stability testing. Failure of product to dissolve may lead to lower levels of anagrelide and an increased risk for clotting or bleeding events. Anagrelide is indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to decrease platelet levels.
DRUG INFORMATION HAPPENINGS • The American Diabetes Association (ADA) has updated the Standards of Medical Care in Diabetes to include updates to the sections on CV disease risk management and CKD risk management. • The American Heart Association (AHA)/American Stroke Association (ASA) has published a guideline on the management of patients with spontaneous intracerebral hemorrhage. • The FDA has published a final rule Q&A on importation of certain prescription drugs from Canada. • The US Preventive Services Task Force (USPSTF) has issued a final statement recommending against screening for chronic obstructive pulmonary disease (COPD) in asymptomatic adults (Grade D).
UPCOMING PRESCRIPTION DRUG/BIOSIMILAR USER FEE ACT (PDUFA/BsUFA) DATES DRUG NAME MANUFACTURER
FORMULATION THERAPEUTIC CLASS
PROPOSED CLINICAL USE
ANTICIPATED FDA APPROVAL
• IV, SC • Mannan-binding lectinassociated serine protease-2 (MASP-2) inhibitor
Hematopoietic stem cell transplant-associated thrombotic microangiopathy
• SC • Entry inhibitor antiviral
Hepatitis D infection (with compensated liver disease) treatment
• IV • Programmed cell death 1 (PD-1) inhibitor
Esophageal squamous cell carcinoma (unresectable, recurrent, locally advanced/ metastatic, after prior systemic therapy)
casirivimab/imdevimab (Regen-Cov) Regeneron
• IM, IV, SC • Antiviral antibodies
COVID-19 treatment (non-hospitalized patients); COVID-19 postexposure prophylaxis
cipaglucosidase alfa Amicus
• IV • Recombinant human acid alpha-glucosidase (rhGAA) enzyme replacement therapy
Pompe disease (in combination with oral miglustat)
roflumilast cream Arcutis/AstraZeneca
• Topical • Phosphodiesterase-4 (PDE-4) inhibitor
Plaque psoriasis (mild – severe)
ranibizumab (biosimilar to Genentech’s Lucentis®) Coherus
• Intravitreal • Vascular endothelial growth factor (VEGF) inhibitor
Wet age-related macular edema; Macular edema following retinal vein occlusion; Myopic choroidal neovascularization (mCNV)
4 | JULY 2022
APPROVALS DRUG NAME MANUFACTURER
New Drugs pegfilgrastim-pbbk (Fylnetra®) Amneal/Kashiv
• BLA approval 05/26/2022; biosimilar to pegfilgrastim (Neulasta®) • Indicated to decrease the incidence of infection, as manifested by
• • • •
vutrisiran (Amvuttra™) Alnylam
febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation Leukocyte growth factor Solution for injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only Recommended dosage is 6 mg SC once per chemotherapy cycle; weight-based dosing is used for pediatric patients weighing < 45 kg
• NDA approval 06/13/2022; Orphan Drug, Standard Review • Indicated for the treatment of polyneuropathy of hereditary transthyretin-
mediated amyloidosis in adults
• Transthyretin-directed small interfering RNA (siRNA) • Solution for injection: 25 mg/0.5 mL in a single-dose prefilled syringe • Recommended dosage is a 25 mg SC injection administered by an HCP once
every 3 months
• Product availability is expected in early July 2022
venlafaxine besylate (Venbysi XR™) Almatica
• 505(b)(2) NDA approval 06/29/2022; Standard Review • Indicated for the treatment of major depressive disorder and generalized
anxiety disorder in adults
• Serotonin and norepinephrine reuptake inhibitor (SNRI) • Oral extended-release (ER) tablet: 112.5 mg • Recommended starting dosage is 112.5 mg once daily with food in patients who
have received ≥ 75 mg of another venlafaxine ER product for ≥ 4 days; dosing may be increased in increments of 75 mg per day, using another venlafaxine ER product, at intervals of ≥ 4 days, up to a maximum of 225 mg per day • Boxed warning for risk of suicidal thoughts and behavior in pediatric and young adult patients 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.
COVID-19 Disclaimer: For more resources on COVID-19, visit the Magellan Rx Coronavirus Update webpage. For the most current information, visit the FDA, CDC, NIH, NIH guidelines, and WHO websites. State and local health departments also provide valuable information regarding management in local communities. As the COVID-19 landscape is fluid, assumptions are subject to change. Glossary: AAP American Academy of Pediatrics
HCP healthcare professional
RNA ribonucleic acid
ACIP Advisory Committee on Immunization Practices
RSV respiratory syncytial virus
BLA Biologics License Application
RT reverse transcription
JAK Janus kinase
SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
BRCA BReast CAncer gene CDC Centers for Disease Control and Prevention CKD chronic kidney disease COVID-19 Coronavirus Disease 2019 CV cardiovascular
mRNA messenger ribonucleic acid NDA New Drug Application NDC National Drug Code NIH National Institutes of Health OTC over-the-counter
PCR polymerase chain reaction
EUA Emergency Use Authorization
Q&A Questions and Answers
FDA Food and Drug Administration
RA rheumatoid arthritis
6 | JULY 2022
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SC subcutaneous TBD to be determined US United States USP United States Pharmacopeia VRBPAC Vaccines and Related Biological Products Advisory Committee WHO World Health Organization