FDA approves vericiguat to reduce HF hospitalization, CV mortality in HFrEF
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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.
Perspective
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Randall Starling, MD, MPH
The approval of vericiguat comes at a time when the HF options proven to reduce mortality and HF hospitalizations have grown and now four unique categories of medications are beneficial. Vericiguat has demonstrated its effectiveness in a unique, specific group of patients that have experienced a worsening HF event. The uptake of this additional drug will relate to ease of use, cost and adoption from providers. The impact of this added medication to save lives and reduce hospitalizations in addition to the approved four pillars of care for HF remains to be demonstrated. The burden for caregivers is to fully utilize the medications proven to save lives.
Initially I anticipate the utilization will be modest. Defining the specific patient populations and characteristics most likely to benefit with reduced hospitalizations and improved quality of life will be important. HF hospitalizations remains a serious challenge and therapies and approaches to reduce rehospitalization is an extremely important public health objective. At least 1 in 5 patients is readmitted within 30 days of every hospitalization for HF at great expense to the health care system.
We now have approved, lifesaving medications for HF that are sadly only being used optimally in far less than half of all HF patients. Our most important mission is to improve the implementation of life saving HF medications for all.
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