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

Executive Summary

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.

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