FDA issues complete response letter for omecamtiv mecarbil
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The FDA has issued a complete response letter to Cytokinetics for omecamtiv mecarbil, an investigational, selective small molecule cardiac myosin activator for treatment of HF with reduced ejection fraction, according to a press release.
In the release, Cytokinetics stated that the FDA is seeking an additional clinical trial for omecamtiv mecarbil to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks, but that the company has no plans to conduct such a trial. The agency noted that data from the pivotal GALATIC-HF trial was “not sufficiently persuasive” to establish substantial evidence for effectiveness for reducing risk for HF events and CV death.
As Healio previously reported, an FDA advisory panel voted 8-3 against supporting the approval of omecamtiv mecarbil, with panelists citing a small observed benefit for a limited group of patients.
In casting their votes, most members of the Cardiovascular and Renal Drugs Advisory Committee said that although the pivotal trial, GALACTIC-HF, met its primary endpoint, the observed benefit in adults with HFrEF was small, did not include a CV mortality benefit and was seen only in patients with a very low EF. Additionally, panelists were concerned with an observed increased risk for myocardial ischemia and worsening HF in patients with baseline atrial fibrillation or flutter, as well as no improvement in quality-of-life measures and a modest effect on HF hospitalization.
Several advisory committee panelists did note that the characteristics of omecamtiv mecarbil allow for its use where current standard of care can be challenging, as many patients with HFrEF are intolerant to current guideline-directed medical therapy.
“This drug has a unique mechanism of action that can address a patient population that really does not have any other options,” Fady Malik, MD, PhD, executive vice president of research and development for Cytokinetics, told Healio before the FDA issued its decision. “As we tried to point put during the meeting, there are many patients for whom current medical therapy can be challenging to implement. Providing more options is to the benefit of patients.”
“This drug has been on a long journey,” Malik said in an interview. “I commend our team for trying to bring an alternative and working with FDA to develop an evidence package that is compelling to the community.”
In the release, Cytokinetics stated that is expects to request a meeting with FDA to understand FDA’s views regarding the complete response letter and what may be required to support potential approval of the drug; however, the company has “no plans to conduct an additional clinical trial of omecamtiv mecarbil.”
The company said its focus remains on the development program for aficamten, a next-in-class cardiac myosin inhibitor currently being tested in the phase 3 SEQUOIA-HCM trial in participants with obstructive hypertrophic cardiomyopathy.
For more information:
Fady Malik, MD, PhD, can be reached at 350 Oyster Point Blvd., South San Francisco, CA 94080.
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