The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction.
The new Prescription Drug User Fee Act (PDUFA) target date is February 28, 2023. The FDA extended the action date by 3 months to review additional pharmacokinetic analyses that were considered to be a major amendment to the application.
Omecamtiv mecarbil is a selective small molecule cardiac myosin activator designed to increase contractility without increasing intracellular calcium in cardiac myocytes or myocardial oxygen consumption.
The application was accepted for review based on data from the phase 3 GALACTIC-HF trial (ClinicalTrials.gov Identifier: NCT02929329), which assessed the efficacy and safety of omecamtiv mecarbil in 8256 adults who were either hospitalized at the time of enrollment for a primary reason of heart failure or had a hospitalization or admission to an emergency room for heart failure within 1 year prior to screening.
Findings from GALACTIC-HF showed that treatment with omecamtiv mecarbil met the primary composite endpoint demonstrating a statistically significant reduction in cardiovascular death or heart failure events compared with placebo. A greater treatment effect of omecamtiv mecarbil was observed in patients with lower left ventricular ejection fraction.
“We are working collaboratively with the FDA as they conduct their review of omecamtiv mecarbil,” said Robert I. Blum, Cytokinetics’ President and CEO. “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.”
Cytokinetics provides regulatory update for omecamtiv mecarbil. News release. Cytokinetics, Inc. Accessed June 17, 2022. https://www.globenewswire.com/news-release/2022/06/17/2464620/35409/en/Cytokinetics-Provides-Regulatory-Update-for-Omecamtiv-Mecarbil.html