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FDA advisory panelist outlines issues with aducanumab’s approval for Alzheimer’s disease

Despite near unanimous objection from its advisory panel, the U.S. Food and Drug Administration (FDA) granted aducanumab approval to treat Alzheimer’s disease on June 7, 2021. In a commentary published in Annals of Internal Medicine, a member and former Chair of the advisory panel and an aducanumab site investigator explain why this unprecedented “accelerated approval” is problematic for clinical research and patient care.