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.

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

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