The US Food and Drug Administration (FDA) has expanded the indication for Novartis’ Entresto (sacubitril/valsartan) to include the risk of cardiovascular death and hospitalisation in adults with chronic heart failure.

Entresto, previously known as LCZ696, was initially approved by the US regulatory agency in July 2015, for the treatment of heart failure with reduced ejection fraction (HFrEF).

The drug has shown superior benefits in patients with left ventricular ejection fraction (LVEF) below normal.

The expanded label indicates LVEF is a variable measure, and advises clinical judgment in deciding whom to treat.

Novartis claimed that it is the first drug to benefit patients diagnosed with both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).

Novartis Pharmaceuticals president Marie-France Tschudin said: “We are proud of our goal to reimagine medicine. This commitment has enabled us to bring Entresto to millions more heart failure patients in the US, many of whom did not have an approved treatment option until now.

“This achievement would not have been possible without tremendous dedication from investigators, patients in our clinical trials and the advocacy community, to whom we are extremely grateful.”

According to the company, patients with heart failure (HF) often face worsening symptoms that result in frequent HF hospitalisations, associated with worsening long-term prognosis.

Its Entresto is a twice-a-day medicine that reduces the strain on the failing heart by enhancing protective neurohormonal systems.

Also, the drug works to inhibit the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS) simultaneously.

The FDA label expansion is supported by efficacy and safety evidence observed in PARAGON-HF, a Phase 3 active-controlled study in patients with guideline-defined HFpEF.

PARAGON-HF executive committee co-chair Scott Solomon said: “This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced.

“Until now, treatment for these patients was largely empiric. We can now offer a treatment to a wider range of patients who have an LVEF below normal.”