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

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

More from US FDA Performance Tracker

More from Regulatory Trackers