Controversial Biogen Alzheimer’s drug faces FDA panel

Nov. 6, 2020

A U.S. FDA advisory committee is meeting today to review Biogen's experimental Alzheimer's disease treatment which, if approved, could be the first treatment to treat the cognitive decline associated with the disease.

The committee of outside experts will review and decide whether to recommend the approval of aducanumab, an antibody designed to remove amyloid plaques from the brain.

On Wednesday morning, the FDA released lengthy briefing documents that in part discussed a June 2019 meeting between the agency and Biogen, stating that the drugmaker had shown “exceptionally persuasive” evidence that its experimental Alzheimer’s disease drug, aducanumab, was effective in a Phase 3 study.

Biogen shares had skyrocketed after the agency released the documents and today were halted in premarket trading in advance of the committee meeting.

But the drug, developed with Tokyo-based partner Eisai, has not been without controversy. Aducanumab's two large Phase 3 trials that were stopped prematurely in March 2019. One trial was trending positive while the other showed no benefits. Biogen stunned analysts by submitting an application for aducanumab in October 2019, announcing that with exposure to a higher dose, the drug showed “reduced clinical decline in patients with early AD.” A paper published in the Journal of the Alzheimer’s Association, Alzheimer’s & Dementia refuted Biogen's argument.

But if all goes well with the committee meeting, an FDA approval could be possible as soon as March 2021, which would make aducanumab the first new treatment for the disease in decades and the first that appears to be able to slow progression.

Read the press statement