ARTICLE | Product Development

β-amyloid becomes surrogate endpoint for Alzheimer’s, despite no clear link to cognitive outcomes

FDA’s decision to approve Biogen’s aducanumab could bring new therapies to patients faster 

June 7, 2021 9:11 PM UTC

FDA’s accelerated approval of aducanumab marks the acceptance of β-amyloid as a surrogate endpoint for Alzheimer’s disease, despite no prior clinical evidence linking the biomarker to cognitive outcomes. The move opens the door to other companies expediting development, and raises the specter that a glut of therapies with unknown clinical benefit could soon enter the market.

FDA planted itself squarely on the side of the amyloid hypothesis in its Monday approval of Aduhelm aducanumab from  Biogen Inc. (NASDAQ:BIIB), though that will likely convince few of the doubters who will continue to point to the lack of solid scientific evidence linking the removal of amyloid plaques with an improvement in cognition. ...