After Leqembi Approval, US FDA In No Rush To Declare Amyloid A Validated Surrogate Endpoint

Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.

Clock in sand
US FDA likely to take its time in making a validation decision about amyloid reduction as a surrogate endpoint. • Source: Shutterstock

Despite the full approval of Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb), the US Food and Drug Administration is not rushing to declare amyloid plaque reduction as a validated surrogate for clinical benefit in Alzheimer’s disease.

The 6 July conversion from accelerated to traditional approval for lecanemab is a watershed moment in Alzheimer’s disease drug development,...

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