Biogen's post-marketing Aduhelm trial: 4 things to know

Biogen is planning a phase 4 post-marketing confirmatory study of Aduhelm, its controversial Alzheimer's drug, the company said in a Dec. 16 news release.

Four things to know:

  1. Biogen is aiming to enroll more than 1,300 people with early Alzheimer’s in the study.

  2. The drugmaker plans to submit the study's final protocol for review to the FDA in March, with patient screening beginning in May. 

  3. Biogen predicts the study will take about four years to complete, meaning the drugmaker won’t have data until 2026.

  4. The study is a post-marketing requirement of the FDA’s accelerated approval pathway.

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