Vericiguat approved to reduce HF hospitalization, CV mortality in HFrEF
Merck announced that the FDA has approved vericiguat to reduce CV death, subsequent HF hospitalization or need for outpatient IV diuretics in adults with symptomatic chronic HF with reduced ejection fraction.
The approval of vericiguat (Verquvo, Merck), a soluble guanylate cyclase stimulator, is based on the results of the pivotal phase 3 VICTORIA trial and follows a priority regulatory review, according to a press release from the company.
As Healio previously reported, vericiguat reduced the incidence of the composite endpoint (HF hospitalization or CV death) compared with placebo among patients with HFrEF (HR = 0.9; 95% CI, 0.82-0.98).
Vericiguat 2.5 mg, 5 mg and 10 mg tablets are being jointly developed with Bayer AG, according to the release.
The drug label contains a boxed warning stating that vericiguat should not be given to pregnant women due to potential fetal harm.
“Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. By some estimates, more than half of these patients are rehospitalized within a month of discharge due to a worsening event and approximately 1 in 5 die within 2 years,” Paul W. Armstrong, MD, cardiologist and distinguished university professor of medicine at the Canadian VIGOUR Centre at University of Alberta, said in the release. “The approval of Verquvo provides doctors, health care professionals and patients with a welcome new option to current available therapies.”
In the VICTORIA trial, vericiguat demonstrated an adverse event profile similar to placebo.