The Food and Drug Administration on Tuesday approved a new heart failure drug developed by Novartis that has been shown to reduce death and hospitalizations from the condition.

Excitement has been growing for the drug, known as Entresto, since the results of a large clinical trial were announced nearly a year ago. Novartis says Entresto could eventually achieve more than $5 billion in annual global sales.

More than 5 million Americans, and an estimated 26 million people worldwide, suffer from heart failure, which can cause shortness of breath, fatigue and retention of fluids and is one of the leading causes of hospitalization, if not the leading cause.

In a clinical trial involving more than 8,400 patients, those randomly assigned to take Entresto had about a 20 percent reduced risk of dying from cardiovascular causes and of being hospitalized for worsening heart failure compared with those being treated with enalapril, a type of drug known as an ACE inhibitor and a standard medicine used to treat heart failure. Patients in both groups could also take other drugs, such as beta blockers, as doctors saw fit.

Many heart failure specialists have said the drug, which was known during its development as LCZ696, could replace the angiotensin-converting enzyme (ACE) inhibitors and related drugs that have been the mainstays of treatment for two decades.

Novartis said that about 2.2 million Americans would be eligible for the drug, which was approved for patients with so-called Class 2 to Class 4 heart failure.

new york times