FDA OKs drug to treat heart failure

The U.S. Food and Drug Administration (FDA) on Tuesday approved Novartis'  Entresto tablets for the treatment of heart failure.

Heart failure is a common condition that affects approximately 5.1 million people in the United States. It is a condition in which the heart can't pump enough blood to meet the body's needs. Heart failure usually worsens over time as the heart's pumping action grows weaker. The leading causes of heart failure are conditions that damage the heart, such as heart attacks and high blood pressure.

Entresto  has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

“Heart failure is a leading cause of death and disability in adults,” FDA Center for Drug Evaluation Division of Cardiovascular and Renal Products Research Director Norman Stockbridge said. “Treatment can help people with heart failure live longer and enjoy more active lives.”

Entresto was reviewed under the FDA’s priority review program, which provides for expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. It was also granted fast-track designation, a program that expedites the review of drugs.

Novartis, based in East Hanover, New Jersey.