FDA approves Verquvo for heart failure.- Merck Inc

The FDA has approved Verquvo (vericiguat), from Merck Inc. for the reduced risk of cardiovascular death and heart failure hospitalization in patients who have received particular care for heart failure (HF). The indication is the first granted for chronic heart failure patients who have been either hospitalized or need outpatient intravenous (IV) diuretics.The approval is based on results from the pivotal phase III VICTORIA trial which observed 10 mg once-daily vericiguat versus placebo in 5050 adult patients with symptomatic chronic HF. At a median follow-up of 11 months, vericiguat was observed to be superior to placebo in reduced event risk based on time-to-event analysis. In the same time period, 90% of patients in both treatment arms were treated with the 10 mg target maintenance dose. The drug's adverse event profile was similar to placebo.