The FDA will convene an advisory committee to discuss Cytokinetics inconsistent heart failure med after all, more than three months after the agency first indicated it would not.
A date or topic list for the meeting has not yet been set but the company expects that to happen later this year; the FDA-set deadline to approve the med remains November 30. The agency had originally indicated earlier this year that it would not hold an advisory committee meeting, according to a release from the company in February.
Omecamtiv mecarbil has had a bumpy trip through the clinic. The FDA's change of heart disclosed by the company is the latest news, after Cytokinetics announced that the therapy failed to improve exercise capacity among heart failure patients with reduced rejection in a phase 3 trial in February.
Those results came more than a year after the company released findings from a larger phase 3 trial involving more than 8,000 patients. That study met its primary endpoint of reducing heart failure events or cardiovascular death compared to a placebo, but failed a secondary endpoint which zeroed in on cardiovascular death. Nearly 20% of patients treated with omecamtiv mecarbil died of a cardiovascular event, the same as placebo.
The results could’ve been worse, but shook the confidence of Amgen, which handed rights to the drug back to Cytokinetics in May 2021 after being partnered for more than 14 years. Cytokinetics has since inked deals worth at least $350 million for omecamtiv mecarbil with Ji Xing Pharmaceuticals and Royalty Pharma.
The drug attempts to counteract heart failure by stimulating cardiac myosin, a protein that helps spur heart contractions. By improving and maintaining heart muscle performance, the hope is that cardiac function will subsequently improve.
Cytokinetics is armed with almost $700 million in cash and investments but is at a critical juncture with expenses as it prepares for potential commercialization. That has ballooned costs, with net losses in the first quarter of this year almost double the year before.
Beyond omecamtiv mecarbil, the company is forging ahead with the development of aficamten, another cardiac myosin inhibitor to treat hypertrophic cardiomyopathies, a condition marked by thickness of the heart muscle. Cytokinetics launched a phase 3 trial of that drug in February.
Editor's note: This story was corrected at 12:40 p.m. ET to reflect that aficamten is a cardiac myosin inhibitor, not an activator.