The list of pharmacologic options for patients with heart failure (HF) has lengthened again with US Food and Drug Administration approval of vericiguat as an addition to other standard HF meds in an especially high-risk HF population, those with an ejection fraction 45% or less and a history of HF hospitalization or an outpatient need for IV diuretics.
Merck, which codeveloped the drug with Bayer, announced the widely anticipated approval today. Merck plans to sell vericiguat the United States as Verquvo; Bayer has the commercialization rights in all other countries, the announcement says.
Vericiguat, which promotes vasodilation through stimulation of a nitric-oxide signaling enzyme pathway, was approved based primarily on the VICTORIA trial, which saw a 10% drop in adjusted risk for the primary end point, cardiovascular death, or first HF hospitalization (P = .019) in those who took the drug, compared with a placebo. The trial’s 5050 patients had entered predominantly in NYHA class 2 or 3 with an HF hospitalization in the previous 6 months or outpatient IV diuretics in the previous 3 months; follow-up averaged 11 months.
The number needed to treat for prevention of one event in the trial was 24, which trialists and some observers considered impressively low despite the drug’s fairly modest primary end point benefit in VICTORIA.
The drug had been initiated at 2.5 mg once daily and escalated to 5 mg/day after 2 weeks and later to 10 mg/day as tolerated; 90% of patients were at 10 mg/day by 1 year, Merck noted in its press release.
A recent VICTORIA analysis suggested that the drug’s benefits had not been influenced by degree of adherence to standard medical therapies at baseline, perhaps alleviating concerns that its clinical effect may not be independent of other medications. Baseline meds in VICTORIA included three standard HF medications in about 60% of patients in the trial. In all, about 93% were on a beta blocker, 73% were on an ACE inhibitor or angiotensin-receptor blocker, another 15% were taking an angiotensin receptor/neprilysin inhibitor, and 70% were on a mineralocorticoid receptor antagonist, Merck said.