Biogen Plans Regulatory Filing for aducanumab in Early Alzheimer’s Disease
If approved, aducanumab would become the first therapy to reduce the clinical decline of early Alzheimer’s disease
Biogen plans to file for market approval in the U.S. for aducanumab based on a new analysis of a larger dataset and discussions with the U.S. Food and Drug Administration (FDA)
With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients. We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.
Analysis of Larger Phase 3 Dataset
The Phase 3 EMERGE study met its primary endpoint, as per the pre-specified statistical analysis plan, showing a statistically significant reduction in clinical decline compared to placebo. Biogen also showed results from a subset of patients in the ENGAGE study, who were randomized to the 10 mg/kg high dose of aducanumab, that support the findings from EMERGE.
- Learn More
Biogen plans to file a Biologics License Application with FDA in early 2020
Biogen will continue dialogue with regulatory authorities in international markets including Europe and Japan
- Learn More