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Cytokinetics Provides Regulatory Update for Omecamtiv Mecarbil
Recent Company Submission in Response to FDA Request Extends PDUFA Date SOUTH SAN FRANCISCO, Calif., June 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics,
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Recent Company Submission in Response to FDA Request Extends PDUFA Date\nSOUTH SAN FRANCISCO, Calif., June 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that, in response to a request from the U.S. Food and Drug Administration (FDA), the company recently provided additional pharmacokinetic analyses of omecamtiv mecarbil related to the company’s new drug application (NDA). After an initial review of the company’s submission, FDA has communicated that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission. “We are working collaboratively with the FDA as they conduct their review of omecamtiv mecarbil,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are committed to bringing forward our first-in-class cardiac myosin activator, which may provide an important treatment option for patients suffering from worsening heart failure.” 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...