Fast track status for omecamtiv in heart failure

June 10, 2020 0 By FM

Fast Track designation has been granted for omecamtiv mecarbil by the USFDA in heart failure.

Omecamtiv is a novel selective cardiac myosin activator, also known as a cardiac myotrope, being developed for the potential treatment of chronic heart failure with a reduced ejection fraction.

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 and CV death in patients with HFrEF.

GALACTIC-HF enrolled 8,256 patients in 35 countries who were either hospitalised at the time of enrollment for a primary reason of heart failure or had a hospitalisation or admission to an emergency room for heart failure within one year prior to screening.