Posted by Michael Wonder on 08 Jul 2020
Biogen completes submission of biologics license application to FDA for aducanumab as a treatment for Alzheimer’s disease
8 July 2020 - If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of Alzheimer’s disease.
Biogen and Eisai today announced that Biogen has completed the submission of a biologics license application to the U.S. FDA for the approval of aducanumab, an investigational treatment for Alzheimer’s disease. The completed submission followed ongoing collaboration with the FDA and includes clinical data from the Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1b PRIME study.
As part of the completed submission, Biogen has requested priority review. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
