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Aduhelm FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 12, 2024.

FDA Approved: Yes (Discontinued) (First approved June 7, 2021)
Brand name: Aduhelm
Generic name: aducanumab-avwa
Dosage form: Injection
Company: Biogen Inc.
Treatment for: Alzheimer's Disease

Aduhelm (aducanumab-avwa) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

Development timeline for Aduhelm

Jan 31, 2024Biogen to Discontinue the Development and Commercialization of Aduhelm (aducanumab-avwa)
Jul  8, 2021FDA Approves Updated Aduhelm Prescribing Information to Emphasize Population Studied in Clinical Trials
Jun 23, 2021Biogen and Eisai Update for the Alzheimer’s Disease Community
Jun  7, 2021Approval FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease
Jan 29, 2021Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
Nov  6, 2020Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease
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)
Nov  6, 2017New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab Presented at 10th Clinical Trials on Alzheimer's Disease
Aug 28, 2017Biogen Reports New Data from Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab

Further information

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