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# Group Urges Postponement of Alzheimer’s Drug Decision
- URL: https://www.fdaweb.com/group-urges-postponement-of-alzheimers-drug-decision/
- Published: 2023-01-05T12:00:00.000Z
- Updated: 2026-09-14T18:10:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153481

Advocacy group Public Citizen is calling on FDA to postpone a 1/6-expected accelerated approval decision on Biogen/Eisai’s Alzheimer’s drug lecanemab until after an advisory committee reviews the data and votes on its risk-benefit profile. In a [1/5 letter](https://www.citizen.org/lecanemab-letter/?ref=fdaweb.com) from Public Citizen’s Health Research Group founder and now-senior advisor **Sidney Wolfe**, the group says FDA’s decision to not convene an advisory committee demonstrates that the agency is “unwilling or unable to learn from its worst approval mistake” — Biogen’s Alzheimer’s therapy aducanumab (Aduhelm).

Last week, a Congressional report was released on FDA’s 2021 controversial review and approval of Aduhelm ([see story](https://www.fdaweb.com/reactions-to-aduhelm-report-blast-fda-closeness-to-industry/)). The report was sharply critical of the agency’s decision to work so closely with the company to guide the drug’s review and approval. It also took issue with Biogen setting an “an unjustifiably high price” despite a lack of demonstrated clinical benefit in a broad patient population.

Public Citizen’s letter cites an 11/2022 article by lecanemab investigators that raised concern about amyloid-related imaging abnormalities with microhemorrhages or hemosiderin deposits occurring in 126 (14.0%) of subjects in the lecanemab group and only 69 (7.7%) of subjects in the placebo group. The authors concluded: “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”

The letter also notes that *Science* magazine “obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures.” It further says that three deaths are thought to be related to lecanemab.

“It seems the unprecedented aducanumab FDA/Biogen axis is still in place,” Wolfe says in his adocacy for the panel meeting so the agency’s approval decision is not further perceived as “yet another Biogen/FDA done deal.”