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Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

 
• By Sue Sutter

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

Rabbit in hat
US FDA pulled a rabbit out of a hat with its surprise use of the accelerated approval pathway for aducanumab. • Source: Alamy

The US Food and Drug Administration’s accelerated approval of Biogen, Inc. and Eisai Co., Ltd.’s Alzheimer’s drug Aduhelm (aducanumab) on the basis of a surrogate endpoint is destined to further inflame the debate over the agency’s use of the expedited pathway and leaves a host of challenges in its wake.

On 7 June, the agency granted accelerated approval to aducanumab, an amyloid beta-directed antibody, for treatment of Alzheimer’s. The FDA...

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• By Bridget Silverman

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• By Vibha Sharma

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EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

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