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Cytokinetics Heart Failure Drug Needs Another Phase III Study, US FDA Panel Says

 
• By Sarah Karlin-Smith

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.

heart
Advisory panel says Cryokinetics needs to do more study for a narrower indication • Source: Shutterstock

Cytokinetics, Inc.’s heart failure treatment omecamtiv mecarbil looks to be headed for a complete response letter following a US Food and Drug Administration advisory panel recommendation that the company conduct a second Phase III study of the drug.

The Cardiovascular and Renal Drugs Advisory Committee voted 8-3 on 13 December that the benefits of the drug do not outweigh its risks for the treatment of heart failure with reduced ejection fraction, though they were open to the possibility that there may be a

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