The U.S. Food and Drug Administration approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning.
Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, pictured above. (Dimitrios Kambouris/Getty Images for EIF)
The U.S. Food and Drug Administration (FDA) approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning.
Vericiguat will be marketed under the brand name Verquvo and is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics. Specifically, it was approved to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
Verquvo, which was jointly developed with Bayer, was approved under priority review based on results from the Phase III VICTORIA study. The VICTORIA study met the primary endpoint by demonstrating a statistically significant reduction of the first occurrence of a composite of cardiovascular death or heart failure hospitalization. The trial was assessing the efficacy of the medication in those patients’ chronic heart patients with reduced ejection fraction (HFrEF). Vericiguat was being tested in combination with available heart failure therapies against placebo. Over the course of the study, there was a 4.2% reduction in annualized absolute risk with Verquvo compared with placebo. Therefore, 24 patients would need to be treated over an average of one year to prevent one primary endpoint event, the companies said in a joint statement.
Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, said clinical studies have shown Verquvo is able to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics.
It is estimated that heart failure impacts more than 60 million people across the globe, with about 6.5 million in the United States. Heart failure with reduced ejection fraction (HFrEF), which has been previously known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase. Approximately 40% to 50% of heart failure patients in the U.S. are estimated to have HFrEF. Of those, about 30% will see their disease worsen, the companies noted. Hospitalization rates increase significantly for those patients and about 20% of these patients with worsening chronic HFrEF will die within two years, the companies noted.
“We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease, Baynes said in a statement.
Michael Devoy, Bayer’s chief medical officer, said the Phase III study was the first positive contemporary outcomes study focused exclusively on a chronic heart failure patient population following a hospitalization for heart failure or need for outpatient intravenous diuretics
“With our strong heritage in the cardiovascular space, Bayer is proud of the first approval of vericiguat in the U.S. and the contribution it will make to improving the lives of those with this debilitating disease,” Devoy said in a statement.
The new heart failure drug does contain a boxed-warning label that indicates Verquvo should not be administered to pregnant women because it may cause fetal harm.
