FDA approves promising heart failure treatment

July 8, 2015

FDA approved sacubitril/valsartan (Entresto, Novartis), an angiotensin receptor neprilysin inhibitor (ARNI), a first-in-class drug for heart failure. It is indicated for patients whose condition is classified NYHA class II-IV, to reduce the risk of cardiovascular death and heart failure hospitalization.

FDA approved sacubitril/valsartan (Entresto, Novartis), an angiotensin receptor neprilysin inhibitor (ARNI), a first-in-class drug for heart failure. It is indicated for patients whose condition is classified NYHA class II-IV, to reduce the risk of cardiovascular death and heart failure hospitalization.

Heart failure affects more than 5 million Americans and is one of the most common reasons for hospitalization in adults 65 years and older. The most common cause of heart failure is coronary heart disease, according to the American Heart Association.

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

In a clinical trial, known as PARADIGM-HF, that enrolled more than 8,000 adults, sacubitril/valsartan was shown to be more effective at lowering the rate of cardiovascular death (20%) and hospitalizations (21%) related to heart failure compared to ACE inhibitor enalapril. Most of the patients were also receiving other treatments for heart failure, such as beta-blockers, diuretics, and mineralocorticoid antagonists.

Side effects associated with sacubitril/valsartan in the clinical trial patients included hypotension, hyperkalemia, renal impairment, and angioedema. Patients who have a prior history of angioedema and black patients are at greater risk of angioedema and should be advised to seek emergency medical attention if this side effect occurs.

The FDA advises that sacubitril/valsartan should not be used with ACE inhibitors because of the increased risk of angioedema. If patients are switched from sacubitril/valsartan to an ACE inhibitor or vice versa, there should be a 36-hour period before the new drug is started.

In addition, women who plan to become pregnant or become pregnant should not use sacubitril/valsartan, FDA warns.