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Home » FDA cites weak efficacy as it hands Cytokinetics CRL for heart failure drug
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FDA cites weak efficacy as it hands Cytokinetics CRL for heart failure drug

March 1, 2023
By Caroline Richards
The U.S. FDA issued Cytokinetics Inc. a complete response letter (CRL) for omecamtiv mecarbil, branding the clinical evidence behind it as not “persuasive” enough to establish its effectiveness for reducing the risk of heart failure events and cardiovascular death. The company is developing the drug as an add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization.
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