Biogen & Eisai Seek Regulatory Approval Of Treatment For Early Alzheimer’s Disease

Biogen and Eisai are seeking regulatory approval from the U.S. Food and Drug Administration (FDA) for an investigational treatment for early Alzheimer’s disease (AD). The treatment is a compound called aducanumab which showed promising outcomes in Phase 3 clinical trials. Biogen and Eisai plan to submit a biologics license application to the FDA in early 2020.

From September 2015 to March 2019, Biogen and Eisai conducted two Phase 3 studies, EMERGE (1,638 participants) and ENGAGE (1,647 participants). The studies were designed to evaluate the efficacy and safety of two dosing regimens of aducanumab. The decision to . . .