Aduhelm: Approval of Alzheimer’s drug was highly unorthodox, finds reportBMJ 2023; 380 doi: https://doi.org/10.1136/bmj.p6 (Published 03 January 2023) Cite this as: BMJ 2023;380:p6
- Janice Hopkins Tanne
- New York
The US Food and Drug Administration and Biogen, manufacturer of the drug for Alzheimer’s disease aducanumab (marketed as Aduhelm), have been heavily criticised by two government committees for the atypical way they collaborated to grant accelerated approval for it.
A report by the Committee on Oversight and Reform and the Committee on Energy and Commerce called for important changes to the FDA’s procedures, saying, “It is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust.”
The committees published a highly critical report after conducting an 18 month investigation into the drug’s regulatory review and approval, pricing, and marketing.1
More than six million people in the US have Alzheimer’s disease, and the number is expected to increase to about 14 million by 2060.
The committees’ report said, “The Food and Drug Administration granted accelerated approval for Aduhelm [in June 2021] …