Biogen, Eisai to face FDA AdCom in June for full approval of Alzheimer's drug

Apr. 10, 2023 1:53 PM ETBiogen Inc. (BIIB), ESALF, ESAIYBy: Dulan Lokuwithana, SA News Editor

The FDA announced Monday that an advisory committee would meet on June 09, 2023, to discuss the marketing application for Leqembi (lecanemab), developed by Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) as a treatment for Alzheimer's disease.
The regulator said that its Peripheral and Central Nervous System Drugs Advisory Committee would meet virtually to discuss the approvability of intravenous Leqembi for the treatment of early Alzheimer's disease.
The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
In January, the FDA granted accelerated approval for the anti-amyloid antibody as a treatment for AD.
Subsequently, the companies submitted a Supplemental Biologics License Application (sBLA) to secure its formal approval. In March, the agency accepted the sBLA granting July 6, 2023, as the target action date for its decision.
According to Seeking Alpha contributor Lane Simonian, the FDA is "more than likely" to grant full approval for Leqembi in July.