Aducanumab Panel Pushes Back On Rosy FDA Outlook, Could Derail A Swift Approval

A US Food and Drug Administration advisory committee review of Biogen, Inc.'s high-profile aducanumab did not go the way the company was hoping – or the way some investors were expecting. Panelists on the Peripheral and Central Nervous System Drugs Advisory Committee, which met virtually on 6 November, voted that the available data does not support the efficacy of aducanumab for the treatment of Alzheimer's disease.

The committee members also voiced skepticism about the favorable light in which the FDA had presented the data in briefing documents released ahead of the meeting. The briefing package, in which the FDA revealed it worked closely with Biogen on the regulatory filing and agreed with much of Biogen's assumptions on the efficacy of aducanumab, unleashed investor enthusiasm for a swift approval. The company's stock jumped 44% to $355.63 on 4 November