Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?
A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.
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Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.
Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.
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.