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

 
• By Sue Sutter

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

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