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US FDA Sees Leqembi Data As Vindicating Its Approach To Alzheimer’s Drugs

 
• By Brenda Sandburg

Two-and-a-half years after Aduhelm’s tumultuous advisory committee, FDA finally gets positive vote it was looking for, albeit on a different product. Leqembi meeting serves to endorse CDR-SB as clinical endpoint as well as amyloid plaque as surrogate for reduction in decline.

Alzheimer's puzzle
FDA touts confidence in connection between amyloid placque reduction and reduction in clinical decline • Source: Shutterstock

The US FDA’s advisory committee vote on 9 June for Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb) offered a strong endorsement of the product, but also constituted something of a victory lap for the agency itself.

The FDA’s view that a reduction in amyloid plaque is reasonably likely to predict clinical benefit has been born out with the results of a confirmatory trial, giving Leqembi a clear path towards traditional approval and

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