Open AccessMaking the Case for Accelerated Withdrawal of Aducanumab
Author(s) -
Peter J. Whitehouse,
Sam Gandy,
Vikas Saini,
Daniel R. George,
Eric B. Larson,
G. Caleb Alexander,
Jerry Avorn,
Shan Brownlee,
Cameron J. Camp,
Howard Chertkow,
Adriane FughBerman,
Robert Howard,
Aaron S. Kesselheim,
Kenneth M. Langa,
George Perry,
Edo Richard,
Lon S. Schneider
Publication year - 2022
Publication title -
journal of alzheimer's disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.677
H-Index - 139
eISSN - 1875-8908
pISSN - 1387-2877
DOI - 10.3233/jad-220262
Subject(s) - alliance , food and drug administration , dementia , opposition (politics) , medicine , political science , psychology , family medicine , public relations , disease , law , pharmacology , pathology , politics
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and advocates for public health met to discuss making a recommendation for whether aducanumab’s approval should be withdrawn.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.