FDA Approves Vericiguat for Use in Patients With Heart Failure
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The U.S. Food and Drug Administration has approved the drug vericiguat for use in patients with heart failure. The drug--a first-of-its-kind, once-daily oral treatment for patients with worsening chronic heart failure--was approved in part thanks to the VICTORIA (Vericiguat Global Study In Subjects With Heart Failure With Reduced Ejection Fraction) clinical study run by researchers at the University of Alberta's Canadian VIGOUR Centre.
As reported in March 2020, vericiguat works by stimulating an enzyme in the body called soluble guanylate cyclase (sGC), which is important for enhancing heart function and helping blood vessels relax to provide better blood flow. In patients with heart failure, sGC is reduced and unable to adequately stimulate cyclic guanosine monophosphate (cGMP), necessary for transmitting chemical signals to blood vessels, which results in vascular and coronary dysfunction.
"We are very pleased to see FDA approval of vericiguat and proud of the collaborative global effort within the VICTORIA study that played in that," said Canadian VIGOUR Centre founding director and U of A distinguished professor of medicine Paul Armstrong.
"This is a safe, well tolerated, once-a-day medicine, and we feel it provides a new and attractive option for a heart failure population at high risk with unmet needs," he added.
Armstrong, who was also the chair of the VICTORIA study, noted that research is a team sport and patient participation played a key role in the success of the study and subsequent regulatory approvals.
"Without the volunteer spirit and participation of patients, the discoveries made in the VICTORIA study would not have been possible," he said.
The VICTORIA study, done in collaboration with a team at Duke Clinical Research Institute in Durham, N.C., compared vericiguat (called Verquvo commercially) with a placebo in adult patients with symptomatic chronic heart failure who had a recent worsening heart failure event. The research team found that rates of death or hospitalization due to heart failure among the patients who received vericiguat were 10 per cent lower than the rates among the placebo group, with an absolute reduction in negative health events in 4.2 per cent of patients who were already receiving optimal heart failure care.
Over the course of the study, 5,050 patients from 600 medical centres across 42 countries were enrolled, including 145 patients from Canada. The study was co-sponsored by pharmaceutical companies Merck Inc. and Bayer AG, which are jointly developing the drug.
Regulatory approvals in other countries and regions, including Canada, are actively underway, Armstrong said. He expects to see these rolling out later in 2021.
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