FDA accepts BLA for lecanemab in early Alzheimer's

Japanese drugmaker Eisai’s (TYO: 4523) shares gained almost 6% to 6,167 yen after, along with partner Biogen (Nasdaq: BIIB), it announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (BAN2401).

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Eisai’s application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.