FDA approves drug to cut death risk in heart patients

The Food and Drug Administration has approved a new heart failure drug from 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 showing a 20 percent reduction in the risk of death from cardiovascular causes or hospitalization for worsening heart failure.

Novartis has predicted that Entresto could eventually achieve more than $5 billion in annual sales globally, making it one of the world’s best-selling medications.

“This is one of those once-in-a-decade kind of breakthroughs, to get a drug that extends life so substantially,” said David Epstein, head of Novartis’ pharmaceutical division.

More than 5 million Americans, and an estimated 26 million people worldwide, suffer from heart failure, in which the heart cannot pump blood adequately to the body’s organs, often as a result of a heart attack or high blood pressure. Heart failure can cause shortness of breath, fatigue and retention of fluids and is one of the leading causes of hospitalization.

Some heart failure specialists have said that Entresto could replace the existing mainstay treatments for chronic heart failure, which are drugs called angiotensin-converting enzyme (ACE) inhibitors or somewhat similar angiotensin II receptor blockers.

Novartis said Entresto would cost about $12.50 a day, or about $4,500 for a year, with two tablets taken daily.

Entresto is a combination of valsartan, the active ingredient in the drug that Novartis sells as Diovan and sacubitril, which inhibits an enzyme known as neprilysin, a new mechanism of action for a heart failure drug.