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FDA Fast Track designation for novel selective cardiac myosin activator in HF

News - May 26, 2020

The Food and Drug Administration (FDA) has given Fast Track designation for a novel selective cardiac myosin activator named omecamtiv mecarbil. This medication is being developed for treatment of heart failure with reduced ejection fraction (HFrEF).

The GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), a phase 3 CV outcomes trial, evaluates whether omecamtiv mecarbil reduces risk of HF events (HF hospitalization and other urgent treatment for HF) and CV death in HFrEF patients. The trial enrolled 8526 patients who were hospitalized at time of enrollment or were hospitalized or admitted to an ER for HF within one year prior to screening. GALACTIC-HF results are expected end of 2020.

Omecamtiv mercarbil is a novel selective cardiac myosin activator, also known as a cardiac myotrope. It binds to the catalytic domain of myosin. Earlier studies have shown that it increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption. Another trial in the phase 3 clinical trials program of omecamtiv mecarbil is METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure) which evaluates the effect of omecamtiv mecarbil compared to placebo on exercise capacity.

Source: press release Amgen, May 8, 2020

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