FDA accepts and grants priority review for BLA of lecanemab for early Alzheimer’s disease under the accelerated approval pathway.
Eisai Co., Ltd. and Biogen Inc. announced that the FDA has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code: BAN 2401), an investigational anti-amyloid beta (A) 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.
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