The Problem of Aducanumab for the Treatment of Alzheimer Disease.

Abstract

Ideas and OpinionsSeptember 2021The Problem of Aducanumab for the Treatment of Alzheimer DiseaseG. Caleb Alexander, MD, MS and Jason Karlawish, MDG. Caleb Alexander, MD, MSJohns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine, Baltimore, Maryland (G.C.A.)Search for more papers by this author and Jason Karlawish, MDUniversity of Pennsylvania, Philadelphia, Pennsylvania (J.K.).Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M21-2603 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail On 7 June 2021, the U.S. Food and Drug Administration (FDA) approved aducanumab for the treatment of Alzheimer disease. Biogen, the owner of the drug, will sell it as Aduhelm. The FDA's decision to approve aducanumab is among its most controversial ever. In this article, we examine the decision's implications for clinical research and patient care.Reverberating Problems With Drug Approval and ResearchAducanumab was approved despite the concerns of scientists and regulatory experts about its efficacy. Notably, an FDA statistician and an advisory committee on which one of us served (G.C.A.) reviewed the product at a November 2020 hearing ...