The approval makes it the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics and is based on the results of the pivotal phase III VICTORIA trial and follows a priority regulatory review. Vericiguat 2.5-mg, 5-mg, and 10-mg tablets are being codeveloped with Bayer AG.
The VICTORIA trial was a randomized, parallel-group, placebo-controlled, double-blind, event-driven, multicenter clinical trial comparing vericiguat with placebo in 5,050 adult patients with symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV) and left ventricular ejection fraction (LVEF) less than 45%, following a worsening heart-failure event. A deteriorating heart-failure event was defined as heart-failure hospitalization within 6 months or less prior to randomization or use of outpatient IV diuretics for heart failure within 3 months or less prior to randomization.
In VICTORIA, the primary endpoint was a composite of time to first event of cardiovascular death or hospitalization for heart failure. The average follow-up for the primary endpoint was 11 months. Vericiguat was superior to placebo in reducing the risk of cardiovascular death or heart-failure hospitalization based on a time-to-event analysis. In the study, vericiguat decreased the incidence of combined cardiovascular death or hospitalization for heart failure over an average 11 months of follow-up (35.5% vs. 38.5%; P = .02). In particular, the benefit of the sGC stimulator was driven by the decline in heart failure hospitalizations.
In the VICTORIA trial, vericiguat demonstrated an adverse-event profile comparable with placebo. The adverse drug reactions occurring more commonly with vericiguat than placebo and in greater than or equal to 5% of patients treated with vericiguat in VICTORIA were hypotension (16% vs. 15%) and anemia (10% vs. 7%). The VICTORIA trial included a total of 2,519 patients treated with vericiguat (up to 10 mg once daily). The average duration of vericiguat exposure was1 year, and the maximum period was 2.6 years. The agent has a boxed warning indicating that it should not be administered to pregnant females since it may cause fetal harm.
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