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Aducanumab Approval Status

Aducanumab (BIIB037) is an investigational human recombinant monoclonal antibody (mAb) in development for the treatment of early Alzheimer’s disease (AD).

Aducanumab is thought to target aggregated forms of amyloid-beta, including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of Alzheimer’s disease patients. Based on pre-clinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque levels.

Development Status and FDA Approval Process for aducanumab

Aug 28, 2017Biogen Reports New Data from Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab
Aug 31, 2016Nature Publishes Results from Pre-Clinical Research and Phase 1b Study of Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab
Sep  8, 2015Biogen Enrolls First Patient in Global Phase 3 Study of Investigational Treatment Aducanumab (BIIB037) for Early Alzheimer’s Disease
Mar 20, 2015Biogen Idec Presents Positive Interim Results From Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab

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