The FDA accepts BLA and grants priority review for lecanemab for treatment of early Alzheimer’s disease under the accelerated approval pathway

Stockholm, July 6, 2022 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code: BAN2401), 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 on January 6, 2023. The acceptance of the BLA by the FDA entitles BioArctic to a milestone payment of MEUR 15 from Eisai.

The release as fetched from its publisher. bioarctic.com ↗