On Friday, June 9th, 2023, the Peripheral and Central Nervous System Drugs Advisory Committee ([PCNS]) 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. The committee will also discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill post-marketing requirement.
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Earlier Event: June 8
Antimicrobial Drugs Advisory Committee
Later Event: June 15
Vaccines and Related Biological Products Advisory Committee (VRBPAC)