In June 2021, the US Food and Drug Administration (FDA) granted accelerated approval of aducanumab (Aduhelm, Biogen), an amyloid-β–directed antibody, for the treatment of patients with Alzheimer disease. As the approval was based on a reduction in amyloid-β plaques observed during clinical trials, not a clinical end point, the FDA required a postapproval trial to verify whether the treatment is beneficial to patients.
The approval of aducanumab is one of the most consequential and criticized decisions the FDA has made in years. The FDA advisory committee vote against approval was nearly unanimous, and the list price for the every-4-weeks maintenance dose of the drug is about $56 000 per patient per year.1
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Steinbrook R. The Accelerated Approval of Aducanumab for Treatment of Patients With Alzheimer Disease. JAMA Intern Med. Published online July 13, 2021. doi:10.1001/jamainternmed.2021.4622
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