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Aducanumab's Big Day Arrives, But How Much Will US FDA Panel Vote Matter?

Executive Summary

Agency thinks Biogen’s sucessful Phase III study supports approval, but given the negative outcome of another trial and disease-modifying mechansim of action, an advisory committee endorsement could go a long way in assuring the public the Alzheimer's drug actually works; the panel will comprise 11 voting members, four of whom were added as temporary members for their expertise in neurology, biostatistics and patient advocacy.

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

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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Our graphical timeline shows Aducanumab’s ups and downs, from IND to accepted BLA, and the many meetings with US FDA staff that helped move the program forward.

Biogen’s Aducanumab: One Positive Phase III Trial Is Good Enough For Demonstrating Efficacy, US FDA Says

Negative results from the Phase III ENGAGE trial – which may have been influenced by imbalance in ‘rapid progressors’ and differential effects of dosing protocol changes – do not negate persuasiveness of positive results from the EMERGE study, agency says in advisory committee briefing document; statistical reviewers dissent, call for a new trial of the Alzheimer's drug.

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