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Amgen:FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

Amgen (AMGN) and Cytokinetics Inc. (CYTK) said that the U.S. Food and Drug Administration has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope, being developed for the potential treatment of chronic heart failure with reduced ejection fraction or 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.

GALACTIC-HF or Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure, one of the largest Phase 3 global cardiovascular or 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.

The results from GALACTIC-HF are expected in the fourth-quarter of 2020.

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