www.fdanews.com/articles/197987-biogen-submits-bla-for-alzheimers-treatment-aducanumab
Biogen Submits BLA for Alzheimer’s Treatment Aducanumab
July 9, 2020
Biogen has submitted a biologics license application to the FDA for its investigational Alzheimer’s treatment aducanumab.
Approval would make aducanumab the first therapy to reduce the clinical decline of Alzheimer’s and to demonstrate that removing amyloid beta resulted in better clinical outcomes.
The FDA has 60 days to decide whether to accept the application. Biogen is seeking a priority review.