Cytokinetics announces FDA acceptance of an NDA for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction.
The FDA assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.
The FDA also indicated that it is currently not planning to hold an advisory committee meeting to discuss the application. The NDA is supported by the results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase III cardiovascular outcomes clinical trial of omecamtiv mecarbil that enrolled over 8,000 patients in 35 countries across 945 sites. GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care.
Additional analyses from GALACTIC-HF demonstrated a greater treatment effect of omecamtiv mecarbil in patients with lower left ventricular ejection fraction (LVEF), as well as other characteristics that may indicate worsening heart failure.
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