Cytokinetics filed with the SEC reporting that the FDA planned to hold an advisory committee meeting to review its New Drug Application (NDA) for omecamtiv mecarbil.
Cytokinetics filed with the Securities and Exchange Commission reporting that the U.S. Food and Drug Administration planned to hold an advisory committee meeting to review its New Drug Application (NDA) for omecamtiv mecarbil. The drug is a small molecule cardiac myosin activator being evaluated in patients with heart failure with reduced ejection fraction (HFrEF). The target action date for the NDA is November 30.
Omecamtiv mecarbil is designed to target the contractile mechanisms of the heart, binding to and recruiting additional cardiac myosin heads that can interact with actin during systole (when the heart muscle contracts and pumps blood from the chambers into the arteries). Cytokinetics reported positive results from the Phase-III GALACTIC-HF trial, where the drug demonstrated a statistically significant effect to reduce the risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events. Those events include hospitalization and other urgent treatments.
On April 3, Cytokinetics announced full results from the METEORIC-HF Phase III trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). Patients receiving the drug had an average change from baseline of pVO2 of -0.2 ml/kg/min compared to 0.2 ml/kg/min in patients on placebo.
The trial evaluated the drug compared to placebo on exercise capacity as evaluated by cardiopulmonary exercise testing (CPET) after 20 weeks of treatment in patients with HFrEF receiving standard of care. There were 276 patients in nine countries. At baseline, patients had an average left ventricular ejection fraction (LVEF) of 27% and an average peak oxygen uptake (pVO2) of 14.7 ml/kg/min. After 20 weeks of treatment, the pVO2 did not change in patients receiving the drug compared to placebo.
Adverse events were similar between treatment arms, even at peak exercise. The METEORIC-HF trial data was not part of the FDA submission.
The GALACTIC-HF study also evaluated cost reduction per patient. In an analysis of a subgroup of 5,369 patients of the 8,256 enrolled, omecamtiv mecarbil was associated with significant risk reduction in risk of a first heart failure event, total heart failure events and cumulative heart failure events. It also significantly decreased resource intensity, measured by total days in hospital among patients being hospitalized. The data, as presented by Dr. Nihar R. Desai, M.D., associate professor of medicine, associate chief, cardiovascular medicine, Yale School of Medicine, Center for Outcomes Research and Evaluation, estimated potential cost reductions within the selected subgroup related to heart failure events of $3,085, a 19% reduction per patients. Of the cost reductions, 99% were from avoiding hospitalizations from heart failure.
Dr. Fady I. Malik, M.D., Ph.D., Cytokinetics’ executive vice president of research & development, said on April 3, “The results of METEORIC-HF continue to emphasize the difficulty of improving exercise capacity in patients with heart failure and reduced ejection fraction even as strides are made to improve clinical outcomes in these same patients. While there was no effect of omecamtiv mecarbil on exercise capacity in METEORIC-HF, we are encouraged that the results further reinforce the overall safety profile of omecamtiv mecarbil observed in GALACTIC-HF.”
He went on to say, “New and additional data from GALACTIC-HF continue to elaborate on our novel cardiac myosin activator including its impact on healthcare resource utilization and its use in both hospital and outpatient settings. These findings further our understanding of the potential benefit omecamtiv mecarbil may have in patients at risk for worsening heart failure, as well as the impact it may have on potential cost savings for the healthcare system.”
