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Time:2019-10-30
Biogen and Eisai announced that they will file for market approval for the drug aducanumab, an investigational treatment for early Alzheimer’s disease, following new analysis showing reduced clinical decline in people with early Alzheimer’s disease.
The Phase 3 clinical studies ENGAGE and EMERGE were discontinued in March 2019 following futility analysis by an independent monitoring committee that indicated the trials were unlikely to succeed.
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.