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Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil
FDA Plans to Convene Advisory Committee Meeting SOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"FDA Plans to Convene Advisory Committee Meeting\nSOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the Company recently participated in a mid-cycle communication meeting with the U.S. Food & Drug Administration (FDA) and was informed that the Agency plans to convene an Advisory Committee meeting for the New Drug Application (NDA) for omecamtiv mecarbil. Cytokinetics expects the FDA to inform it of the date and topics for the Advisory Committee Meeting in a subsequent communication. A late-cycle communication meeting has been proposed to occur later this year. Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF). The FDA has assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022. About Omecamtiv Mecarbil Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Omecamtiv mecarbil is designed to increase the number of active actin-myosin cross bridges during each cardiac cycle and consequently augment the impaired contractility that is associated with heart failure with reduced ejection fraction (HFrEF). Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.2-4 The development program for omecamtiv mecarbil is assessing its potential for the treatment of HFrEF. Positive results from GALACTIC-HF, the first Phase 3 clinical trial of omecamtiv mecarbil 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. No reduction in the secondary endpoint of time to CV death was observed. Adverse events and treatment discontinuation of study drug were balanced between trea...