Aducanumab and Accelerated Approval: Where Do We Go From Here?

The reviews the fallout from the aducanumab approval, arguing that the decision was problematic because amyloid plaque reduction has never been validated as a clinical trial surrogate for Alzheimer’s disease, the FDA’s own statisticians found no patient-level correlation between the surrogate and clinical outcomes, and the approval undermined the credibility of the accelerated approval pathway.