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Making the Case for Accelerated Withdrawal of Aducanumab

Whitehouse, Peter; Gandy, Sam; Saini, Vikas; George, Daniel R; Larson, Eric B; Alexander, G Caleb; Avorn, Jerry; ... Schneider, Lon; + view all (2022) Making the Case for Accelerated Withdrawal of Aducanumab. Journal of Alzheimer's Disease 10.3233/JAD-220262. (In press).

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Abstract

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and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn.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.

Type: Article
Title: Making the Case for Accelerated Withdrawal of Aducanumab
Location: Netherlands
DOI: 10.3233/JAD-220262
Publisher version: https://content.iospress.com/journals/journal-of-a...
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Aducanumab, Alzheimer’s disease, monoclonal antibody
UCL classification: UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10147193
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