Posted by Michael Wonder on 07 Aug 2020
FDA accepts Biogen's aducanumab biologics license application for Alzheimer's disease with priority review
7 August 2020 - If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease.
Biogen and Eisai today announced that the U.S. FDA has accepted the biologics license application for aducanumab, an investigational treatment for Alzheimer’s disease.
The application has been granted priority review, with a Prescription Drug User Fee Act action date on 7 March 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review.
