Posted by Michael Wonder on 06 Jul 2022
The U.S. FDA accepts and grants priority review for Eisai's biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
6 July 2022 - Eisai and Biogen announced today that the U.S. FDA has accepted the biologics license application under the accelerated approval pathway for lecanemab (development code: BAN2401), an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer's disease (collectively known as early Alzheimer's disease) 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 action date of 6 January 2023.
