Making the Case for the Accelerated Withdrawal of Aducanumab

Authors

Peter J. Whitehouse, Case Western Reserve UniversityFollow

Document Type

Article

Publication Date

5-31-2022

Abstract

U.S. Food and Drug Administration-s (FDA) approval of aducanumab (Aduhelm® in the US) as a treatment for mild cognitive impairment of the Alzheimer type and Alzheimer-s disease has raised such major concerns about efficacy, safety, FDA processes, and regulatory capture that Biogen-s license to market this biologic should be immediately withdrawn. Aducanumab has not demonstrated benefit to patients, failed to meet regulatory guidelines, and is likely to cause both individual and societal harm.

Keywords

accelerated approval, aducanumab, Alzheimer's disease, clinical trials, FDA

Publication Title

Journal of Alzheimer's Disease

Rights

© Whitehouse & Vikas, 2022. The definitive, peer reviewed and edited version of this article is published in Journal of Alzheimer's Disease, vol. 87, no. 3, pp. 999-1001, 2022, https://doi.org/10.3233/JAD-220264.

Comments

This is an Accepted Manuscript of an article published by IOS Press in the Journal of Alzheimer's Disease on May 31, 2022, available at: https://doi.org/10.3233/JAD-220264

Recommended Citation

Whitehouse, Peter J., "Making the Case for the Accelerated Withdrawal of Aducanumab" (2022). Faculty Scholarship. 59.
https://commons.case.edu/facultyworks/59