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Eisai/Biogen’s Lecanemab Faces Smoother Passage Through US FDA Than Aducanumb

 
• By Sue Sutter

With amyloid plaque reduction established as a surrogate endpoint by Aduhelm’s accelerated approval for Alzheimer’s disease, lecanemab is unlikely to face an advisory committee before its 6 January user fee goal date.

Smooth sailing
The regulatory sailing should be smoother for Eisai/Biogen's second-in-class amyloid-targeted antibody lecanemab. • Source: Shutterstock

Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s disease treatment lecanemab should see smoother passage through the US Food and Drug Administration given the precedent set by the still-controversial accelerated approval of the companies’ Aduhelm (aducanumab-avwa) based upon the surrogate endpoint of amyloid plaque reduction.

The FDA has granted priority review to lecanemab, an anti-amyloid beta protofibril antibody, under the accelerated approval pathway and set a user fee goal date of 6 January, the

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