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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...

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