The FDA announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee on June 9, 2023, from 10 a.m. to 5 p.m. Eastern Time. The committee will discuss supplemental biologics license application 761269/s-001, for LEQEMBI, or lecanemab solution for intravenous infusion, submitted by Eisai (ESALY) for the treatment of early Alzheimer’s disease. This product was approved under 21 CFR 314.500 for the treatment of Alzheimer’s disease. Confirmatory studies are studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The committee will discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill postmarketing requirement 4384-1 detailed in the January 6, 2023, approval letter, available at URL Reference Link
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly
See the top stocks recommended by analysts >>
Read More on BIIB:
- JPMorgan sees favorable risk/rewards for Eli Lilly, Biogen into data
- Biogen appoints Keeney as Head of Corporate Development
- Biogen Appoints Adam Keeney as Head of Corporate Development
- Biogen announces detailed analyses from phase 2 study of Lecanemab
- Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting