Merck gets FDA approval for its new heart drug

Merck & Co. Inc. (NYSE: MRK) announced that the US Food and Drug Administration (FDA) has approved Verquvo for the treatment of patients with chronic heart failure with an ejection fraction of less than 45%. The US company developed the drug together with its German partner Bayer. The drug, Vericiguat, is a soluble guanylate cyclase (sGC) stimulator that the companies will market under the brand name Verquvo. Verquvo is designed to reduce the risk of cardiovascular death and the number of hospitalizations for heart failure or the need for outpatient IV diuretic therapy in patients with symptomatic chronic heart failure and an ejection fraction of less than 45%. Interestingly, the approval of the drug comes with a warning that pregnant women should not receive the drug as it can cause fetal harm. The FDA granted approval based on the positive data from the Phase III VICTORIA study. The randomized, double-blind, multicentre, event-driven, placebo-controlled study evaluated Vericiguat in combination with other heart failure therapies versus placebo in over 5,000 patients with symptomatic chronic heart failure. The results indicated that vericiguat was more effective at reducing the risk of cardiovascular death and hospitalization for heart failure when compared to placebo. Most importantly, the data showed that Vericigaut reduced the absolute annual risk by 4.2 compared to placebo. The jointly developed Vericigaut tablets are available in doses of 2.5 mg, 5 mg and 10 mg. Dr. Roy Baynes, SVP and global director of clinical development at Merck Research Laboratories, said Verquvo has shown that it can reduce the risk of cardiovascular death and hospitalization for heart failure after hospitalization or the need for outpatient IV diuretic treatment. He added that the company is pleased to offer such a meaningful treatment alternative for symptomatic patients with chronic heart failure. Baynes said the approval builds on the company's massive history in developing therapies for cardiovascular disease. Entresto is currently approved by Novartis (NYSE: NVS) for the treatment of HFrEF, but Vericigaut will be the first chronic heart failure drug to be approved for heart failure patients after hospitalization or when needed for outpatient intravenous diuretics.