FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options

THOUSAND OAKS, CA (STL.News) 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.

NOTE: this is NOT the complete release.