An advisory committee’s overwhelmingly negative verdict on Biogen, Inc.’s Aduhelm (aducanumab), coming in the face of a highly positive US Food and Drug Administration review of the Alzheimer's disease drug's efficacy data, has left some observers asking whether the agency could opt for an accelerated approval.
Use of this expedited regulatory pathway on the basis of Alzheimer’s biomarker data as a surrogate marker appears unlikely for...