FDA rejects Cytokinetics' heart failure drug, but the biotech has a backup
The FDA rejected Cytokinetics’ lead candidate for heart failure, saying the company didn’t provide enough evidence of the drug’s efficacy.
Cytokinetics revealed Tuesday that it received a complete response letter from the FDA for omecamtiv mecarbil to treat heart failure with reduced ejection fraction.
According to the company, the FDA determined that the Phase III trial, GALACTIC-HF, was “not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction.”
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