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.
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Public Citizen proposal that FDA staff who provide presubmission advice on a development program not be involved in reviewing the subsequent product application would cause significant public health repercussions and delay drug development, acting commissioner says; Public Citizen had cited ‘close collaboration’ between the FDA and Biogen on aducanumab in calling for the separation.
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.
From EMBARK data to labeling materials, the potential reasons for the three-month user fee delay are as varied as the ups and downs of the Biogen/Eisai Alzheimer’s candidate’s development saga.