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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Alzheimer’s Drug & Dermatitis JAK inhibitor Among New EU Filings
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.
What Did US FDA Do Wrong In Its Review Of Aducanumab? AdCom Members Have A List
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.
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.