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

 
• By Jessica Merrill

An FDA advisory committee panel were critical of the agency’s review package for Biogen's aducanumab, raising uncertainty about the prospects of approval.

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FDA's aducanumab advisory committee meeting puts the review off track • Source: Shutterstock

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...

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