Medscape March 19, 2024
The US Food and Drug Administration (FDA) embraced the use of biomarkers and surrogate endpoints in its most recent guidance on developing therapeutics for early Alzheimer’s disease (AD).
The agency’s draft guidance is the first update since 2018 for products aimed at the earliest stages of the disease, which the FDA defines as stages 1, 2, and 3. Such guidance — when it is made final, after public comment closes in mid-May — is considered a template that will guide discussions between the FDA and drug makers and help determine the structure of clinical trials.
It is considered the FDA’s “current thinking on the topic,” and should not be construed as “legally enforceable responsibilities,” the FDA document, which was published...
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