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Aducanumab FDA Approval Status

Reviewed by J.Stewart BPharm. Last updated on Jul 8, 2020.

FDA Approved: No
Generic name: aducanumab
Company: Biogen
Treatment for: Alzheimer's Disease

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.
  • On October 22, 2019, Biogen and Eisai announced plans to pursue regulatory approval for aducanumab after an earlier decision to discontinue the global Phase 3 trials ENGAGE and EMERGE. Results of a futility analysis had indicated that the trials were unlikely to meet their primary endpoint upon completion. Biogen now believes that results from a subset of patients in the Phase 3 ENGAGE Study who received sufficient exposure to high dose aducanumab support the findings from EMERGE.
  • On July 8, 2020, Biogen announced the completion of the Biologics License Application submission to the FDA for aducanumab as a treatment for Alzheimer’s disease. 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.

Development Timeline for aducanumab

Aug  7, 2020FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
Jul  8, 2020Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease
Oct 22, 2019Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies
Mar 21, 2019Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer’s Disease
Oct 26, 2018Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD)

Further information

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