FDA to Decide on Lecanemab’s Approval in January 2023
The U.S. Food and Drug Administration (FDA) has agreed to review an application from Eisai seeking accelerated approval of lecanemab (BAN2401), an investigational amyloid-targeting antibody to treat early Alzheimer’s disease in people with confirmed amyloid plaques in the brain. Eisai finished the rolling application a few months ago.