FDA Grants Fast Track Designation for Omecamtiv Mecarbil in Heart Failure

THOUSAND OAKS, Calif., and SOUTH SAN FRANCISCO, Calif., May 08, 2020 (GLOBE NEWSWIRE) — Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope,¹ being developed for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF).
Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need for such a disease or condition.“This Fast Track designation represents an important milestone in the development of omecamtiv mecarbil,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition.”“We are pleased that the FDA has granted Fast Track designation for omecamtiv mecarbil for the potential treatment of heart failure,” said Robert I. Blum, president and chief executive officer of Cytokinetics. “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.”GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), one of the largest Phase 3 global cardiovascular (CV) outcomes studies in heart failure ever conducted, is designed to evaluate whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) and CV death in patients with HFrEF. GALACTIC-HF enrolled 8,256 patients in 35 countries 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 one year prior to screening. Dose selection for omecamtiv mecarbil in this study uses a blood test. Top-line results from GALACTIC-HF are expected in Q4 2020.About Omecamtiv Mecarbil and the Phase 3 Clinical Trials Program
Omecamtiv mecarbil is a novel, selective cardiac myosin activator, also known as a cardiac myotrope,¹ that binds to the catalytic domain of myosin. Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. ^2-4 Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier. Omecamtiv mecarbil is the subject of a comprehensive Phase 3 clinical trials program composed of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), a Phase 3 clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on CV outcomes and METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity.About Heart Failure
Heart failure is a grievous condition that affects more than 64 million people worldwide⁵ about half of whom have reduced left ventricular function.^6,7 It is the leading cause of hospitalization and readmission in people age 65 and older.^8,9 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.¹⁰ An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.^11,12About Amgen 
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.