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FDA Advisors Reject Cytokinetics’ Heart Failure Candidate

FDA Advisors Reject Cytokinetics’ Heart Failure Candidate

Cytokinetics’ omecamtiv mecarbil received an 8-3 thumbs-down from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, with the majority agreeing that the risks of the myosin activator outweigh its benefits for treating patients with heart failure and reduced ejection fraction.

“The benefits seen were small, and if you remove the urgent outpatient visits [from the composite endpoint], they were no longer statistically significant,” said Steve Nissen of the Cleveland Clinic. “If there was even a quality-of-life benefit I’d be encouraged. But despite a trial with 8,000 patients, there wasn’t any evidence of a meaningful quality-of-life improvement, and that makes it less attractive.”

Cytokinetics was counting on the rather equivocal results from its single phase 3 trial, GALACTIC-HF. At 8,000 subjects, the study was the second-largest cardiac study ever conducted, according to FDA briefing documents. While the trial succeeded on its primary endpoint — a combination of cardiovascular death or heart failure — the benefit was quite small.

The FDA’s decision date on the NDA is Feb. 28, 2023.

December 15, 2022


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