What Did US FDA Do Wrong In Its Review Of Aducanumab? AdCom Members Have A List
Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.
You may also be interested in...
Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.
US FDA’s Peter Stein says drug’s mechanism of action is relevant to all stages of Alzheimer’s disease. While clinical trials enrolled only those with mild disease as indicated on a PET scan, labeling has no limitations on use of Aduhelm. An FDA advisory committee member resigns from the panel in response to the approval.
Dunn’s participation at the panel meeting ended speculation that he left the US FDA.