Early Alzheimer's Disease Treatment Review Scheduled for June 2023
A meeting of the U.S. FDA's Peripheral and Central Nervous System Drugs Advisory Committee is scheduled for June 9, 2023.
This FDA Committee's digital presentation will discuss the supplemental biologics license application for LEQEMBI™ (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for treating early Alzheimer's disease (AD).
The Committee will discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill post-marketing requirement 4384-1, detailed on January 6, 2023, FDA approval letter.
Confirmatory studies verify and describe a product's clinical benefit after receiving an FDA accelerated approval. Accordingly, its application was granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.
LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody, not a preventive vaccine.
As of April 15, 2023, the FDA has not approved any Alzheimer's vaccine candidate.
FDA advisory committees provide independent expert advice on topics or specific products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations.
The FDA generally follows these recommendations but is not legally bound to do so.