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

 
• By Sue Sutter

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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US FDA believes the Phase III EMERGE trial can stand on its own as pivotal efficacy evidence for aducanumab. • Source: Shutterstock

Biogen, Inc.’s successful EMERGE study can stand on its own as pivotal efficacy evidence for the Alzheimer’s disease drug aducanumab despite the negative results from a second Phase III trial, the US Food and Drug Administration said.

In advisory committee briefing documents released 4 November, the agency said the negative ENGAGE trial (Study 301) “does not contribute...

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