Merck & Co. Inc. (NYSE:MRK) has announced that the US FDA has approved its verquvo for treatment of chronic heart failure patients with ejection fraction less than 45%. The US Company jointly developed the drug with its German partner Bayer.
Merck’s verquvo approved
The drug, vericiguat is a soluble guanylate cyclase (sGC) stimulator the companies will market under the brand name Verquvo. Verquvo will be useful in the reduction of cardiovascular death risk and heart failure hospitalization, after heart failure hospitalization or the need for outpatient IV diuretics in patients with symptomatic chronic heart failure as well as less than 45% ejection fraction.
Interestingly the drug’s approval comes with a warning indicating that pregnant women should not receive it because it can cause fetal harm. The FDA gave the approval based on positive Phase III VICTORIA study data. The randomized, double-blind, multicentre, event-driven, placebo-controlled study examined vericiguat in combination with other heart failure therapies versus placebo in over 5,000 symptomatic chronic heart failure.
Results indicated that vericiguat was more effective relative to placebo in reduction of cardiovascular death risk and heart failure hospitalization. Most importantly, the data indicated that there was a 4.2 reduction in yearly absolute risk with vericigaut relative to placebo. The jointly developed vericigaut tablets are available in 2.5 mg, 5mg, and 10 mg.
Vericiguat becomes the first after heart failure hospitalization treatment
Merck Research Laboratories’ SVP and global clinical development head president Dr. Roy Baynes said that Verquvo has shown that it can reduce cardiovascular death risk and heart failure hospitalization after heart failure hospitalization or the need for outpatient IV diuretics. He added that the company is delighted to offer such a meaningful treatment alternative for symptomatic chronic heart failure patients. Baynes said that the approval builds on the company’s massive history of creating cardiovascular disease treatment therapies.
Currently, Novartis’s (NYSE:NVS) Entresto has approval for treating HFrEF but vericigaut will be the first chronic heart failure treatment to receive approval for heart failure patients after hospitalization or in need of outpatient intravenous diuretics.