乌鸦传媒

Heart failure patients won't be getting another drug on the market in the form of omecamtiv mecarbil, now that FDA rejected approval of the cardiac myosin activator.

The agency thus followed the advice of its Cardiovascular and Renal Drugs Advisory Committee, which this past December voted 8-3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF).

Yet some had hoped that the drug would be approved because it would fill an unmet need for people with advanced heart failure who are often intolerant to existing therapies on the market.

"We are disappointed with this outcome, especially considering the high unmet need for innovative treatments for patients suffering from worsening heart failure," said Robert Blum, drugmaker Cytokinetics' president and CEO, in a . "We are humbled by the support of the heart failure community and will engage with FDA and consider what may be next steps for omecamtiv mecarbil in the U.S."

FDA officials are asking for another clinical trial to better gauge omecamtiv mecarbil's effectiveness -- which won't be happening, at least on Cytokinetics' end.

The company said it is redirecting development efforts to aficamten, its next-in-class cardiac myosin inhibitor currently in a in obstructive hypertrophic cardiomyopathy. This drug has the potential to replicate the success of mavacamten (Camzyos), which was acquired by Bristol Myers Squibb for and approved by the FDA in April 2022.

Omecamtiv mecarbil's new drug application mostly hinged on the phase III GALACTIC-HF trial, which showed that it modestly reduced the combined rate of cardiovascular death and hospitalization or other urgent treatment for heart failure over a median 21.8 months (37.0% vs 39.1% with placebo, HR 0.92, 95% CI 0.86-0.99).

There was no evidence of longer survival or improved quality of life among study participants given the cardiac contractility drug. Furthermore, the subgroup with atrial fibrillation or atrial flutter had excess cardiovascular deaths.

Seeing these results, Amgen, the co-developer of the drug, backed out of further development and returned the rights of omecamtiv mecarbil to Cytokinetics in .

"FDA communicated that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic [HFrEF]," Cytokinetics confirmed.

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