Biogen’s Aducanumab Falls Hard At Panel Review, Leaving US FDA In A Tight Spot
Successful EMERGE trial does not provide substantial evidence of efficacy in Alzheimer’s because it cannot be divorced from its unsuccessful sister study, advisory committee says; panel’s unequivocal rejection leaves agency’s Office of Neuroscience in a tight spot given its strong support for the drug and the help it gave Biogen to get this far.
You may also be interested in...
US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings
Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.
US FDA asked a very typical question of its advisory committee about Cytokinetics’ omecamtiv mecarbil: is there ‘substantial evidence’ of efficacy? But in this case the issue wasn’t a trial that was too small or clearly flawed – it was whether such a large, rigorous trial should have shown more than it did.
Without directly referencing the agency’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm, CDER director Patrizia Cavazzoni defended US FDA’s ability to decide on use of the expedited pathway during an application review, while also stressing the need for earlier planning on evidence generation and confirmatory trials.