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FDA Updates for Week of Nov. 29, 2021


In COVID-19 news, an advisory committee recommends approval of oral antiviral after Merck releases updated data. The FDA made three approvals this week: an imaging agent to detect ovarian cancer and a vaccine for hepatitis B, and Darzalex Faspro is given an additional indication. New regulatory applications include: Lynparza for early breast cancer; the psoriasis therapy deucravacitinib, a pneumococcal vaccine for children, and an anemia therapy. The regulatory agency also paused the updated clozapine REMS program.

Advisory committee recommends authorization of the COVID-19 anti-viral molnupiravir.

The FDA’s Antimicrobial Drugs Advisory Committee has voted 13 to 10 to support emergency authorization of Merck/Ridgeback’s oral anti-viral to treat mild-to-moderate COVID-19 in adults.

The narrow vote comes just after Merck announced analysis of updated data that indicated molnupiravir may not be as effective as first thought. Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, phase 3 study.

FDA approves imaging agent to detect ovarian cancer.

The FDA has approved Cytalux (pafolacianine), an imaging agent intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

To date, there have been limited ways for surgeons to assess the location and extent of cancerous tissue while operating. Developed by On Target Laboratories, Cytalux is comprised of a near-infrared dye and a targeting molecule that binds to receptors overexpressed on cancer cells. Specifically, it targets folate receptors commonly found on many cancers, such as ovarian cancer.

A single dose of the agent is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared imaging system.

FDA approves vaccine for hepatitis B.

The FDA has approved PreHevbrio, a recombinant vaccine for the prevention of hepatitis B in adults 18 years of age and older. PreHevbrio, developed by VBI Vaccines, contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved three-antigen hepatitis B virus vaccine for adults in the United States.

VBI expects to make PreHevbrio available in the United States in the first quarter of 2022.

Darzalex Faspro gets new multiple myeloma indication.

Janssen’s profitable Darzalex Faspro (daratumumab and hyaluronidase-fihj) garnered a new indication from the FDA.

The agency approved the medication, in combination with Kyprolis (carfilzomib) and dexamethasone, to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

Darzalex Faspro is already approved for several multiple myeloma indications as well as AL amyloidosis, which is caused by the accumulation of an immunoglobulin light chain protein.

FDA grants priority review for Lynparza for early breast cancer.

The FDA has accepted and granted priority review of the supplemental new drug application for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer. The FDA has set a Prescription Drug User Fee Act date during the first quarter of 2022.

Lynparza is approved in the United States, EU, Japan and several other countries for the treatment of patients with germline BRCA-mutated, HER2-negative metastatic breast cancer previously treated with chemotherapy.

Lynparza was developed and is commercialized jointly by AstraZeneca and Merck. It is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response in tumors harboring a deficiency in mutations in BRCA1 and/or BRCA2.

FDA accepts BMS application for psoriasis therapy.

The FDA has accepted Bristol Myers Squibb’s new drug application for deucravacitinib, a first-in-class therapy for the treatment of adults with moderate-to-severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022. Additionally, the European Medicines Agency has validated the Marketing Authorization Application for deucravacitinib.

Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor is designed to selectively target TYK2.

These applications were based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily deucravacitinib in patients with moderate-to-severe plaque psoriasis versus placebo and Amgen’s Otezla (apremilast).

Merck submits application for Vaxneuvance for children, adolescents.

The FDA has accepted for priority review a supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. The FDA set a Prescription Drug User Fee Act date of April 1, 2022.

The application is based on results from phase 2 and phase 3 clinical studies in infants, children, and adolescents.

Vaxneuvance was approved in July 2021 for use in those 18 years of age and older for the prevention of invasive disease caused by the S. pneumoniae. Previously, the vaccine had received breakthrough therapy designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks through 17 years of age.

FDA accepts for priority review supplemental application of Reblozyl.

The FDA has accepted for priority review the supplemental biologics license application for Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent beta thalassemia. The FDA has set a Prescription Drug User Fee Act goal date of March 27, 2022.

In addition, the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia. Reblozyl is being co-developed and co-commercialized by Bristol Myers Squibb and Merck, following Merck’s recent acquisition of Acceleron Pharma.

FDA pauses clozapine REMS program.

The FDA is temporarily suspending certain Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements to ensure continuity of care.

In August 2021, the FDA announced that had it the modified the Clozapine REMS program, requiring pharmacies that dispense clozapine to obtain a pre-dispense authorization and health care professionals to re-enroll their patients in the program. That change began Nov. 15, 2021.

But in a recent announcement, the FDA indicated there were difficulties with implementation of the new program, including a high call volume and long call wait times. Regulators are making two temporary changes to the program.

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