The NDA has been assigned standard review with a PDUFA target action date in late November 2022.
US Food and Drug Administration (FDA)
The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF).
The NDA has been assigned a standard review with a Prescription Drug Use Fee Act (PDUFA) target action date of November 30, 2022. Currently, no FDA advisory committee meeting is planned to discuss the application.
In a statement, Cytokinetics Incorporated’s President and CEO Robert I. Blum expressed his excitement for this milestone in the commercial launch of the company’s treatment agent.
“More than two million people in the U.S. with HFrEF have signs and symptoms of worsening heart failure despite standard of care therapy, pointing to a clear unmet medical need for more treatment options,” Blum said. “We look forward to engaging with the FDA to bring this potential new medicine to patients later this year.”
Its NDA is supported by results from the phase 3 GALACTIC-HF clinic trial, which enrolled over 8,000 patients across 945 sites in 35 countries.
Findings from the study showed omecamtiv mecarbil had a statistically significant effect on the reduction of risk of the primary composite endpoint of cardiovascular death or heart failure events, compared to placebo.
Additionally, analysis from GALACTIC-HF observed a greater treatment effect of omecamtiv mecarbil in patients with lower left ventricular ejection fraction (LVEF) and other characteristics related to worsening heart failure.
No reduction in the secondary endpoint of time to CV death was observed. Adverse events and treatment discontinuation were balanced between study treatment arms.
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator. It is the first of a novel class of myotropes that directly target the contractile mechanism of the heart, binding to and recruiting cardiac myosin heads to interact with actin during systole.
The agent is manufactured to increase the number of active actin-myosin cross bridges during each cardiac cycle and accordingly augment the impaired contractility associated with HFrEF.
A second phase 3 clinical trial of omecamtiv mecarbil entitled METEORIC-HF was designed to evaluate the effect of treatment compared to placebo on exercise capacity, with results expected in early 2022.