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.
On March 21, 2019, Biogen and Eisai announced the decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. The decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion. The recommendation to stop the studies was not based on safety concerns.
Development Status and FDA Approval Process for aducanumab
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