The Food and Drug Administration (FDA) has granted Fast Track designation to omecamtiv mecarbil (Amgen) for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF).
Omecamtiv mecarbil is a novel cardiac myosin activator that increases contractility without increasing intracellular calcium in cardiac myocytes or myocardial oxygen consumption. The investigational drug is being evaluated in the GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) placebo-controlled phase 3 study.
The trial includes 8265 patients 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.
Patients were randomized to receive either omecamtiv mecarbil or placebo twice daily plus standard of care. The primary outcome measure is the time to cardiovascular death or first heart failure event through study completion, up to 208 weeks. Top-line results from the trial are expected in the fourth quarter of 2020.
Commenting on the study, Robert I. Blum, president and chief executive officer of Cytokinetics, said: “The prevalence of heart failure is growing with our aging demographics, and GALACTIC-HF is designed to assess the clinical effects of our novel myosin activator in patients meaningfully at risk.”
Omecamtiv mecarbil is also being investigated in the METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure) phase 3 study. The study is comparing the effects of treatment with omecamtiv mecarbil to placebo on exercise capacity in patients with HFrEF.
For more information visit amgen.com.