Aducanumab Fall-Out: An Inexpedient Use Of ‘Expedited’ Review
The aducanumab review involved everything sponsors might think they could want from the US FDA, with the agency taking a hands on approach to expedite a complex and difficult review in hopes of delivering an important new therapy to patients as quickly as possible. Unfortunately, in this case, FDA seems to have expedited the review right over a cliff.
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The intensely negative advisory committee for Biogen’s proposed Alzheimer’s therapy was a shocker. Would it have happened if US FDA had been able to convene an in-person event instead of a ‘virtual’ one?
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.