Making the Case for Accelerated Withdrawal of Aducanumab

Peter Whitehouse, Sam Gandy, Vikas Saini, Daniel R. George, Eric B. Larson, G. Caleb Alexander, Jerry Avorn, Shannon Brownlee, Cameron Camp, Howard Chertkow, Adriane Fugh-Berman, Rob Howard, Aaron Kesselheim, Kenneth M. Langa, George Perry, Edo Richard, Lon Schneider

Research output: Contribution to journalArticlepeer-review

11 Scopus citations


The controversial approval in June 2021 by the Food and Drug Administration (FDA) of aducanumab (marketed as Aduhelm), Biogen's monoclonal antibody for patients with Alzheimer's disease, raises significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost. On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. Attendees considered arguments both in favor of and in opposition to withdrawal and voted unanimously to recommend that the FDA withdraw its approval for aducanumab and to support the Right Care Alliance's filing of a formal Citizen Petition to this effect.

Original languageEnglish
Pages (from-to)1003-1007
Number of pages5
JournalJournal of Alzheimer's Disease
Issue number3
StatePublished - 2022


  • Aducanumab
  • Alzheimer's disease
  • monoclonal antibody


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