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.
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Biogen faces complex logistics in shutting down a multinational trial with more than 200 sites and approximately 1,000 patients enrolled; company also is facing calls to publish data collected from the unfinished study as well as other aducanumab trials.
The advisory committee review of US WorldMeds’ eflornithine for neuroblastoma was remarkable for the unusual nature of the efficacy data to support the NDA – and also for who spoke on behalf of the agency and how effectively they walked the panel through a complex set of issues.
Agency’s presentations on Biogen/Ionis’ ALS drug included differing viewpoints from the statistical and clinical pharmacology teams; the transparency and emphasis on a multidisciplinary review approach may reflect lessons learned from missteps at the Aduhelm panel review in 2020.