Alex Berg*, Ryan P. Mayers*, and Sarah Richards*
Edited by Sharon Jiang and Friederike M. C. Benning
Article | Aug. 29 2022
*Emails: email@example.com, firstname.lastname@example.org, email@example.com
- The recent approval of Aduhelm, a medicine indicated for Alzheimer’s disease, sparked controversy in part due to reliance on biomarkers instead of primary data showing cognitive improvement
- The use of biomarker surrogate endpoints enables medicines to make it from bench to bedside faster but reduces the certainty that these medicines show clinical efficacy
- Future policy should build on the lessons from the Aduhelm approval, consider how biomarkers are chosen, and balance the risk of using biomarkers with their potential benefit to patients with neurodegenerative diseases
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