Affiliations: [a]
Case Western Reserve University, Cleveland, OH, USA
| [b]
University of Toronto, Toronto, Ontario, Canada
| [c]
Lown Institute, Needham, MA, USA
Correspondence:
[*]
Correspondence to: Peter J. Whitehouse, MD, PhD, 2895 Carlton Road, Shaker Heights, OH 44122, USA. Tel.: +1 216 470 2931; E-mail: peter.whitehouse@case.edu.
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safety, FDA processes, and regulatory capture that Biogen–s license to market this biologic should be immediately withdrawn.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
