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
FDA’s decision to approve Biogen’s aducanumab could bring other new treatments to patients faster, but the benefit of those treatments could be uncertain.
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