Drugs

Cytokinetics NDA for Heart Failure Drug

FDA has accepted for review a Cytokinetics NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating heart failure with reduced ejection fraction (HFrEF). The agency set a user fee review action target date of 11/30.

The submission is based on data from the 8,000-patient GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) Phase 3 cardiovascular outcomes clinical trial. According to the company, GALACTIC-HF demonstrated that omecamtiv mecarbil had a statistically significant effect in reducing risk of the primary composite endpoint of cardiovascular 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,” it says.

Cytokinetics says omecamtiv mecarbil is designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. It is also intended to increase the number of active actin-myosin cross bridges during each cardiac cycle, which augments the impaired contractility that is associated with heart failure with reduced ejection fraction.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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