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Biogen: towards request for drug approval for Alzheimer's

(CercleFinance.com) - Biogen and Eisai announce that after consulting the US Food and Drug Administration (FDA), Biogen plans to seek regulatory approval for aducanumab, an experimental treatment for early-stage Alzheimer's disease.


The pharmaceutical companies say that this application, which will be filed in early 2020, will be based on the Emerge Phase III study, which achieved its primary endpoint by demonstrating a significant reduction in the clinical decline.


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