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Single Trial, Missing Companion Diagnostic May Be Insurmountable Hurdles for Cytokinetics Heart Failure Drug

 
• By Sarah Karlin-Smith

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.

person falling over hurdle
FDA advisory committee preview documents negative for Cytokinetics heart failure drug. • Source: Shutterstock

Cytokinetics, Inc. heart failure drug didn’t meet the US Food and Drug Administration’s bar for approval on a single-Phase III trial, agency briefing documents released ahead of a 13 December Cardiovascular and Renal Drugs Advisory Committee meeting indicate.

The underwhelming Phase III study result is just one of many problems FDA reviewers identified in the application for omecamtiv mecarbil, though likely the key one as it’s doubtful the...

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