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Biogen’s Aducanumab Falls Hard At Panel Review, Leaving US FDA In A Tight Spot

 
• By Sue Sutter

Successful EMERGE trial does not provide substantial evidence of efficacy in Alzheimer’s because it cannot be divorced from its unsuccessful sister study, advisory committee says; panel’s unequivocal rejection leaves agency’s Office of Neuroscience in a tight spot given its strong support for the drug and the help it gave Biogen to get this far.

FDA Advisory Committee Feature image
Aducanumab lacks substantial evidence of efficacy for Alzheimer's treatment, a US FDA panel said.

A US Food and Drug Administration advisory committee’s unequivocal rejection of the approvability of Biogen, Inc.’s Alzheimer’s disease drug Aduhelm (aducanumab) puts the Center for Drug Evaluation and Research and its Office of Neuroscience in a difficult position.

The office can stand by its view, espoused by director Billy Dunn and the clinical review team for the biologics license application, that a single Phase III trial (Study 302) was sufficiently robust to demonstrate efficacy and supports aducanumab’s approval as the

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