In an effort to ease drug development for Alzheimer’s disease, the Food and Drug Administration is endorsing a new approach that would rely on biomarkers to approve medicines before patients show any signs of the illness, instead of demonstrating a drug alleviates symptoms.
To entice researchers, the agency would accelerate approval of a drug for people who do not show indications they have the disease if the treatment has an effect on a biomarker, according to a draft guidance released on Thursday. The agency did not specify any biomarkers, but presumably, this could include beta amyloid or tau, which are proteins believed responsible for triggering the disease.
Once a drug becomes available, a drug maker would then have to conduct additional studies to confirm its treatment offers a benefit, notably a change in cognition. This would also amount to a significant policy revision, because the FDA previously looked for treatments that could provide changes in function, as well as cognition.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
