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# ‘Put Aduhelm Approval on Hold’: Researchers
- URL: https://www.fdaweb.com/put-aduhelm-approval-on-hold-researchers/
- Published: 2022-11-16T12:00:00.000Z
- Updated: 2026-09-14T18:06:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153209

Worldwide academic medical center researchers led by **Abass Alavi** from the Hospital of the University of Pennsylvania Department of Radiology say FDA should pause its approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease. Writing in a *Journal of Alzheimer’s Disease* [commentary](https://content.iospress.com/articles/journal-of-alzheimers-disease/jad220841?ref=fdaweb.com), Alavi says the approval should be paused while the agency investigates the researchers’ questions about the amyloid hypothesis that they say has dominated Alzheimer’s research and treatment trials for 30 years.

They particularly question the use of amyloid-PET scanning to show whether new therapies can reduce cerebral amyloid deposits and thus inhibit the development of Alzheimer’s disease. The researchers say such a finding contributed to FDA’s approval of Aduhelm, despite the inability of an advisory committee to find evidence of a favorable clinical benefit.

“We believe this kind of PET scanning is questionable and has misled FDA into making a decision contrary to the agency’s foremost mission to protect the public health,” Alavi wrote. “Background for the approval is a never proven ‘amyloid hypothesis’ suggesting that Alzheimer’s disease is caused by cerebral amyloid deposits. Instead of reducing the amount of amyloid in the brain, we fear that Aduhelm and similar drugs cause increased brain damage. In addition to our concerns, we suspect that the amyloid PET scans performed are not reflecting amyloid removal, but rather are indicative of increased therapy-induced brain damage.”