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Lessons Still To Learn: Cytokinetics’ Omecamtiv Is Over In The US, But FDA Debriefs Could Inform European Strategy

 
• By Bridget Silverman

Cytokinetics will not conduct the new trial in heart failure with reduced ejection fraction (HFrEF) required by the FDA’s complete response letter for omecamtiv mecarbil.

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• Source: Shutterstock

Cytokinetics, Inc. will not continue to pursue US FDA approval of its lead cardiac myosin activator, omecamtiv mecarbil, after receiving a complete response letter, but the company will use its opportunity for a post-CRL meeting with the agency to gain insights that could improve the drug’s chances of approval overseas.

The omecamtiv mecarbil NDA for treatment of patients with heart failure with reduced ejection fraction (HFrEF) was based on a single pivotal trial, the 8,200-patient Phase III GALACTIC-HF study.

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