ARTICLE | Regulation
The amyloid debate’s next phase: presymptomatic Alzheimer’s disease
FDA guidance suggests identifying asymptomatic patients via biomarkers. Could digital endpoints and patient-reported outcomes fill the gap?
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That question is at the heart of the debate around FDA’s recent draft guidance on developing drugs for the earliest stages of Alzheimer’s disease. ...