The committee will discuss supplemental biologics license application (sBLA) 761269/s-001, for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of Alzheimer's disease, initiated in patients with mild cognitive impairment or mild dementia stage of disease. This product was approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) 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 post-marketing requirement 4384-1 detailed in the January 6, 2023, approval letter, available at www.accessdata.fda.gov/drugsa...
8 июн 2023
