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.
- 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 aducanumab. 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 would 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.
- On January 31, 2024, Biogen Inc. announced that they would discontinue the development and commercialization of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use and would terminate the ENVISION clinical study. This decision was not related to any safety or efficacy concerns. A large portion of the resources released resulting from termination of the Aduhelm program will be redeployed in Biogen’s AD franchise.
Development timeline for Aduhelm
Further information
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