Biogen’s Aducanumab And The Case For A Medicare-Driven Clinical Trial
Peter Bach warns against Medicare ceding its scientific authority to FDA and automatically covering all drugs and devices the agency clears, suggesting the Alzheimer’s drug be subject to a CMS Innovation Center trial if FDA-approved. Others say the drug could highlight flaws in Medicare Part B’s payment system.
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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.
USA FDA Gives Biogen Big Hand In Effort To Get Its Alzheimer’s Treatment On The Market
In unusual move, FDA formed ‘working group’ collaboration with Biogen to conduct further analyses of two aducanumab studies after the Phase III trials were halted. Agency concluded drug’s effectiveness in one of the studies is ‘robust and exceptionally persuasive’ and advised Biogen that it was ‘reasonable’ to submit a marketing application.