FDA AdCom to convene on June 9th to discuss Biogen/Eisai’s LEQEMBI in AD

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