What happened to Aduhelm in the end?
Medicare restricted it to clinical trial patients, major health systems refused to stock it, and Biogen discontinued the drug on January 31, 2024 — a cautionary chapter for accelerated approval based on an unconfirmed surrogate biomarker.
Medicare restricted coverage to patients enrolled in qualifying clinical trials, citing the significant unknowns and potential for harm. Several health systems, including the Cleveland Clinic and the Department of Veterans Affairs, declined to offer it. European regulators refused to approve it.
On January 31, 2024, Biogen announced it was discontinuing Aduhelm, winding down trials by May 2024 and ceasing supply to existing patients in November 2024. Biogen and its partner Eisai shifted focus to a next-generation antibody, lecanemab. The Alzheimer's Association credited Aduhelm's approval with opening a new era of treatments, while critics saw its trajectory as a cautionary tale about accelerated approval on a surrogate marker without confirmed clinical benefit.