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.