ARTICLE | Regulation
FDA guidance suggests identifying asymptomatic patients via biomarkers. Could digital endpoints and patient-reported outcomes fill the gap?
By Selina Koch, Executive Editor
June 13, 2024 12:43 AM UTC
Ask virtually anyone in the Alzheimer’s drug development community and they’ll tell you that anti-amyloid mAbs promise the most benefit when used early in disease, ideally before symptoms start. But how many healthy people should be exposed to a drug class with serious safety risks to prevent a fraction of them from becoming symptomatic?
That question is at the heart of the debate around FDA’s recent draft guidance on developing drugs for the earliest stages of Alzheimer’s disease. …
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- Source: https://www.biocentury.com/article/652673/the-amyloid-debate-s-next-phase-presymptomatic-alzheimer-s-disease