Seven questions for FDA’s adcomm raised by Biogen’s aducanumab data

As the advisory committee meeting on Nov. 6 for Biogen’s anti-amyloid therapy aducanumab to treat Alzheimer’s disease swiftly approaches, seven key questions could make the agenda.

Approval of the mAb is far from certain. The data package Biogen Inc. (NASDAQ:BIIB) submitted to FDA contains results from two Phase III studies, ENGAGE and EMERGE. Neither study has a complete dataset, given both were stopped after an interim futility analysis suggested one would not meet its primary cognitive endpoint. ...