FDA On What Aduhelm AdCom Got Wrong: Statistics, Investigational Drugs, Patient Perspective

The advisory committee review of aducanumab in November was a bruising affair for the US Food and Drug Administration, with a near unanimous vote against the drug and several pointed remarks directed to the agency by panelists about what they saw as an overly collegial relationship with the sponsor. FDA’s subsequent decision to grant accelerated approval of the Alzheimer’s drug suggested that the agency basically ignored the advisory committee, but newly released documents show that reviewers actually engaged in an extensive effort to downplay and dispute the panel’s conclusions. 

The committee erred in endorsing the findings of FDA’s statistical reviewers, failed to consider the similar treatment effects on clinical endpoints of two investigational drugs, and gave inadequate weight to the patient perspective, FDA reviewers said