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Aduhelm FDA Approval History

Last updated by Judith Stewart, BPharm on July 15, 2021.

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

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

Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
  • 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 clinical 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 later determined that results from a subset of patients in the Phase 3 ENGAGE Study who received sufficient exposure to high dose aducanumab supported 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.
  • On November 6, 2020, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted against recommending the drug. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA.
  • On June 7, 2021, the FDA granted accelerated approval for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of Aduhelm in patients with Alzheimer’s disease.
  • Aduhelm is administered as an intravenous infusion over approximately one hour every four weeks.
  • Aduhelm may cause serious adverse reactions including Amyloid Related Imaging Abnormalities (ARIA) and hypersensitivity reactions. Common adverse reactions include ARIA-Edema, headache, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and falls.

Development timeline for Aduhelm

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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