FDA Approves Vericiguat for High-risk Patients With HF
The approval, the first from the FDA in 2021, follows the positive results from the VICTORIA trial presented last year at ACC.
The US Food and Drug Administration has approved vericiguat (Verquvo), a drug that targets cyclic guanosine monophosphate (cGMP), as a means to lower the risk of cardiovascular events in high-risk patients who have symptomatic, chronic heart failure with reduced ejection fraction (HFrEF). Merck, the drug’s manufacturer, announced the news today.
Specifically, the novel agent is approved for reducing cardiovascular mortality and HF hospitalizations in HFrEF patients requiring outpatient IV diuretic therapy or hospitalization. The approval is based on the results of the 5,050-patient VICTORIA trial, which was presented by Paul Armstrong, MD (Canadian VIGOUR Centre/University of Alberta, Edmonton), at the virtual American College of Cardiology (ACC) 2020 Scientific Session.
In that study, reported by TCTMD, vericiguat was associated with a relative 10% lower risk of cardiovascular death or HF hospitalization when compared with placebo in patients treated with guideline-directed medical therapy. The primary endpoint of the trial—cardiovascular mortality or HF hospitalization—occurred in 35.5% of patients treated with vericiguat compared with 38.5% of those who received placebo (P = 0.02) over a median follow-up of 10.8 months, a benefit that was driven by a reduction in hospitalizations for HF.
Vericiguat stimulates soluble guanylate cyclase (sGC) to produce cGMP and restore nitric oxide sensitivity. By increasing cGMP production, vericiguat decreases arterial constriction and arterial stiffness, Armstrong explained during last year’s ACC presentation.
Merck. Merck announces US FDA approval of Verquvo (vericiguat). Published on: January 20, 2021. Accessed on: January 20, 2021.
- Merck and Bayer sponsored the VICTORIA trial.