Cytokinetics Inc. (CYTK) said that the U.S. Food & Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction or HFrEF.
The New Drug Application (NDA) for omecamtiv mecarbil is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2023.
The FDA will consider the recommendation made by the advisory Committee in its review of the NDA but is not bound to the Committee's recommendation.
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator. If approved by the FDA, omecamtiv mecarbil will become the first therapy indicated for HFrEF that directly targets the mechanisms of the heart responsible for contraction - or its pumping function.
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