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:
- Biogen is aiming to enroll more than 1,300 people with early Alzheimer’s in the study.
- The drugmaker plans to submit the study's final protocol for review to the FDA in March, with patient screening beginning in May.
- Biogen predicts the study will take about four years to complete, meaning the drugmaker won’t have data until 2026.
- The study is a post-marketing requirement of the FDA’s accelerated approval pathway.