Too Big To Succeed? Cytokinetics Heart Failure Trial Proves Too Much For FDA Committee
US FDA asked a very typical question of its advisory committee about Cytokinetics’ omecamtiv mecarbil: is there ‘substantial evidence’ of efficacy? But in this case the issue wasn’t a trial that was too small or clearly flawed – it was whether such a large, rigorous trial should have shown more than it did.
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Additional trial of omecamtiv mecarbil should be focused on the narrower group of heart failure patients that the initial Phase III study seemed to suggest may have a favorable risk-benefit calculus with the drug, Cardiovascular and Renal Drugs Advisory Committee members told FDA.
Single Trial, Missing Companion Diagnostic May Be Insurmountable Hurdles for Cytokinetics Heart Failure Drug
Cytokinetics willingness to tweak the indication for omecamtiv mecarbil doesn’t look likely to help the drug get past a handful of safety and efficacy concerns at its 13 December advisory panel.