BASEL, Switzerland — Novartis has received Food and Drug Administration approval for Entresto (sacubitril/valsartan) tablets, a medication for heart failure with reduced injection fraction.

Entresto is seen as a breakthrough medication for heart failure patients.

An angiotensin receptor neprilysin inhibitor (ARNI), Entresto reduces the strain on a failing heart. The twice-a-day tablet acts to enhance the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system.

The company said Entresto will be available by prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalization. It is usually administered with other heart failure therapies in place of an ACE inhibitor or other angiotensin receptor blocker.

“Millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital,” stated David Epstein, division head at Novartis Pharmaceuticals. “We recognize our responsibility to ensure Entresto reaches U.S. patients and prescribers as soon as possible and will begin shipping in the U.S. in the coming week.”

Nearly 6 million people in the United States suffer from heart failure, and about half have the reduced ejection fraction form. About 2.2 million of these patients have heart failure classified as NYHA II-IV, based on how much their symptoms limit their physical activity. Patients with heart failure face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life.

The FDA’s decision is based on results from the 8,442-patient PARADIGM-HF study, which was stopped early when it was shown that Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril, according to Novartis. At the end of the study, patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril, the company said.

“The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers,” commented Dr. Milton Packer, professor and chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center. “Entresto is expected to change the management of patients with HFrEF for years to come.”