FDA approves Bayer/Merck & Co heart failure drug

Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market.

Verquvo has been approved to reduce risk of cardiovascular death and heart failure hospitalisation in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

The drug can be used after hospitalisation for heart failure or in patients in need of intravenous diuretics.

But the drug is entering an increasingly competitive market, where Novartis and AstraZeneca are vying for supremacy.

Entresto (sacubitril+valsartan) was FDA-approved in patients with reduced ejection fraction five years ago.

Meanwhile, AstraZeneca’s Farxiga (dapagliflozin), originally a diabetes drug, was approved in the US last year in heart failure with reduced ejection fraction.

The FDA is also quickly reviewing Boehringer Ingelheim’s Jardiance (empagliflozin) in heart failure, AZ’s big rival in the market for SGLT2 inhibitor class drugs.

Verquvo’s approval is the first for patients following a hospitalisation for heart failure or who need for outpatient IV diuretics and is based on the results of the pivotal phase 3 VICTORIA trial and follows a priority regulatory review.

VICTORIA’s main efficacy goal was to determine whether Verquvo is superior to placebo, both in combination with other heart failure therapies, in reducing the risk of cardiovascular death or heart failure hospitalisation in adults with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event.

Verquvo met the primary efficacy objective, with the study showing there was a 4.2% reduction in annualised absolute risk in the treatment group compared with placebo.

Therefore, 24 patients would need to be treated over an average of one year to prevent one death or heart failure hospitalisation.

VICTORIA is a large phase 3 trial involving 5,050 patients with heart failure with ejection fraction less than 45%.

Dr Paul W. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial, said: "Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalisation after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalisation.

"By some estimates, more than half of these patients are rehospitalised within a month of discharge due to a worsening event and approximately one in five die within two years.

"The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies."