FDA Issues New Guidance for Early Alzheimer’s Drug Development

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). This is crucial when many individuals in the earliest phases of AD may have mild cognitive decline but no functional decline, the agency added. The agency’s draft guidance is the first update since 2018 for products aimed at the earliest stages of the disease, which the FDA defines as stages 1, 2, and 3.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.

Link: Medscape (03/2024)