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Biogen Expects Confirmatory Aduhelm Data In 2026, But Is It Too Late?

Data on rivals will be available well before

 
• By Jessica Merrill

Biogen's update on the timeline for running a confirmatory study of the Alzheimer's treatment is faster than the nine years required by FDA under the accelerated approval.

Biogen
Biogen plans to begin an Aduhelm confirmatory study in May • Source: Alamy

Biogen, Inc.'s Phase IV post-marketing confirmatory trial of Aduhelm for the treatment of Alzheimer's disease is on track to begin enrolling patients in May 2022 – with the expectation that data will be available in 2026. By then, the safety and efficacy profile of beta amyloid clearing antibodies will already be clearer, informed by rival drugs.

Biogen updated investors and the public on 16 December on the timeline for the confirmatory trial, required by the US Food and Drug Administration as part of the accelerated approval...

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