FDA updates for week of November 29, 2021


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

The advisory committee recommends authorization of the COVID-19 antiviral molnupiravir.

The FDA’s Antimicrobial Drug Advisory Committee voted 13-10 to support emergency clearance of the oral antiviral drug from Merck / Ridgeback to treat mild to moderate COVID-19 in adults.

The restricted vote comes just after Merck announced analysis of updated data indicating that molnupiravir may not be as effective as initially thought. Merck now claims that molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after analyzing all the data. Previously, an interim analysis showed a 50% reduction in hospitalizations or deaths.

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.

FDA Approved Cytalux (pafolacianin), an imaging agent to help surgeons identify cancerous lesions of the ovary. The medicine is designed to improve the ability to locate other cancerous tissue in the ovary which is normally difficult to detect during surgery.

To date, surgeons have had limited means to assess the location and extent of cancerous tissue during surgery. Developed by On Target Laboratories, Cytalux is composed of a near infrared dye and a targeting molecule that binds to overexpressed receptors on cancer cells. Specifically, it targets folate receptors commonly found in many cancers, such as ovarian cancer.

A single dose of the agent is given by intravenous infusion before surgery to help the surgeon identify other malignant tissue during the operation using a near infrared imaging system.

FDA approves hepatitis B vaccine.

FDA 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 surface antigens of HBV and is the only three-antigen hepatitis B virus vaccine approved for use in adults in the United States.

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

Darzalex Faspro obtains a new indication in multiple myeloma.

Janssen’s cost-effective Darzalex Faspro (daratumumab and hyaluronidase-fihj) has obtained a new indication from the FDA.

The agency approved the drug, 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 treatment.

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

The FDA grants priority review for Lynparza for early breast cancer.

FDA has accepted and prioritized the review of the additional new drug application for Lynparza (olaparib) for the adjuvant treatment of patients with early high-risk negative high-risk epidermal growth factor receptor 2 breast cancer human (HER2) mutated BRCA. The FDA has set a prescription drug user fee bill date for the first quarter of 2022.

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

Lynparza was developed and is jointly marketed by AstraZeneca and Merck. It is a first-in-class PARP inhibitor and the first targeted therapy to block the response to DNA damage in tumors with deficient mutations in BRCA1 and / or BRCA2.

The FDA accepts BMS’s request for the treatment of psoriasis.

FDA has accepted New drug application from Bristol Myers Squibb for deucravacitinib, a first-class therapy for the treatment of adults with moderate to severe plaque psoriasis. The FDA has set the deadline for the Prescription Drug User Fee Act on September 10, 2022. In addition, the European Medicines Agency has validated the marketing authorization application for deucravacitinib.

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

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

Merck submits application for Vaxneuvance for Children and Adolescents.

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

The request is based on the results of phase 2 and phase 3 clinical studies in infants, children and adolescents.

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

The FDA accepts the additional application for Reblozyl for priority review.

FDA has accepted for the priority consideration of the additional biologic license application for Reblozyl (luspatercept-aamt), a first-class erythroid maturation agent, for the treatment of anemia in adults with non-dependent beta-thalassemia. transfusions. The FDA has set the deadline for the Prescription Drug User Fee Act on March 27, 2022.

In addition, the European Medicines Agency has validated the type II variation for Reblozyl in beta thalassemia of NTDs. Reblozyl is co-developed and co-marketed by Bristol Myers Squibb and Merck, following the recent acquisition of Acceleron Pharma by Merck.

FDA suspends REMS clozapine program.

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

In August 2021, the FDA announced that it had the amended the Clozapine REMS program, requiring pharmacies dispensing clozapine to obtain pre-dispensing authorization and healthcare professionals to re-enroll their patients in the program. This change began on November 15, 2021.

But in a recent announcement, the FDA said there were challenges with implementing the new program, including high call volume and long wait times. The regulators are making two temporary changes to the program.


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