FDA Denies Cytokinetics’ NDA for Heart Failure Drug

The FDA has said no to Cytokinetics’ new drug application (NDA) for omecamtiv mecarbil, an investigational treatment for heart failure with reduced ejection fraction (HFrEF).

Cytokinetics said it received a Complete Response Letter (CRL) from the FDA in which the agency said the company’s 8,000-patient phase 3 trial comparing omecamtiv mecarbil with standard-of-care therapy “is not sufficiently persuasive to establish substantial evidence of effectiveness.”

The FDA emphasized in the letter that results from an additional clinical trial of omecamtiv mecarbil — a selective, small molecule cardiac myosin activator — are required to establish substantial evidence of effectiveness “with benefits that outweigh the risks.”

Cytokinetics said it will seek a meeting with the FDA “in order to understand FDA’s views regarding the CRL” and what may be required to support the drug candidate’s approval.