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Eisai/Biogen Maintain Lead Over Lilly In New Race To Alzheimer’s Approval

Full Approval Filing May Quickly Follow Accelerated US FDA Decision

 
• By Mandy Jackson

The US FDA accepted an application for accelerated approval and set a 6 January action date, giving lecanemab ample time to reach the market ahead of Lilly’s competing anti-amyloid antibody donanemab.

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Eisai/Biogen have a nearly two-month lead over Lilly • Source: Shutterstock

Eisai Co., Ltd. and Biogen, Inc. remain at least a few months ahead of Eli Lilly and Company in the race to win accelerated approval and rapidly bring a second amyloid-targeting antibody to market in the US. Eisai and Biogen announced on 5 July that the Food and Drug Administration accepted their biologics license application (BLA) for lecanemab and granted priority review, setting a 6 January action date for the early Alzheimer’s disease therapy.

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