FDA Update for the Week of Oct 17, 2022


In COVID-19 news, the FDA issued an EUA for Novavax booster. The agency has extended review time for new ALS therapy and accepted a supplemental NDA for Camzyos. Additionlly, the FDA granted six months pediatric exclusivity for Eylea.

Novavax COVID-19 vaccine booster gets FDA EUA.

Novavax’s COVID-19 vaccine (NVX-CoV2373) has received emergency use authorization (EUA) from the FDA for a first booster dose at least six months after completion of primary vaccination. The EUA applies to people 18 years of age and older for whom an mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to people 18 years of age and older who elect to receive the Novavax COVID-19 vaccine, Novavax said in a statement.

The FDA’s EUA decision for the Novavax booster was based on data from the phase 3 Prevent-19 clinical trial and from the UK-sponsored COV-BOOST trial. In the phase 3 trial, antibody levels increased significantly relative to pre-boost levels, rising above levels associated with protection.

The FDA granted EUA for a two-dose primary series in adults aged 18 and older in July and for adolescents aged 12 through 17 in August. Following those EUAs, the CDC recommended the vaccine for use as a primary series for both age groups.

FDA extends review time for Biogen’s ALS therapy.

The FDA has extended the review of tofersen to treat patients with amyotrophic lateral sclerosis (ALS). Tofersen is being evaluated specifically to treat patients with superoxide dismutase 1 (SOD1) ALS. Developed by Ionis Pharmaceuticals and licensed to Biogen, toferson is an antisense drug that binds to SODI mRNA, which leads to its degradation.

In July, the FDA had accepted the a new drug Application (NDA), granting the application priority review and given a Prescription Drug User Fee Act action date of Jan. 25, 2023. At the time, the FDA indicated that it is planning to hold an advisory committee meeting for this application.

Biogen submitted responses to information requests by the FDA, which the agency considers a major amendment that will require additional time for review. The updated PDUFA date is April 25, 2023.

FDA accepts supplemental application for Camzyos.

The FDA has accepted Bristol Myers Squibb’s supplemental new drug application (sNDA) for Camzyos (mavacamten) for an expanded indication to reduce the need for septal reduction therapy (SRT), which is a procedure to treat hypertrophic cardiomyopathy. HCM is a chronic, progressive disease that make it hard for the heart to pump blood. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 16, 2023.

The FDA approved Camzyos in April 2022. It addresses the excessive contraction of the heart that leads to severe disease where the blood flow is obstructed. It is thought to work by decreasing the number of actin-myosin cross-bridges, which reduces the heart muscle’s ability to contract. Camzyos is only available through a restricted REMS program because of the risk of heart failure due to systolic dysfunction.

FDA grants six months pediatric exclusivity for Eylea.

The FDA has granted pediatric exclusivity to Eylea (aflibercept), which currently under regulatory review for retinopathy of prematurity (ROP) in preterm infants. Retinopathy of prematurity is a leading cause of blindness in children, and each year between 1,100 and 1,500 infants develop the disease. The target action date for the FDA decision is Feb. 11, 2023, and U.S. market exclusivity has been extended by an additional six months through May 17, 2024.

Bayer and Regeneron are collaborating on the global development of Eylea, and Regeneron maintains exclusive rights in the United States.

Eylea is currently available to treat patients with age-related macular degeneration, diabetic macular edema and diabetic retinopathy. It is a VEGF inhibitor that is injected into the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye.

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