FDA approves new heart failure drug

By Sally Robertson, B.Sc.Jul 9 2015

A new drug called Entresto has been approved by the U.S Food and Drug Administration (FDA) for the treatment of heart failure.

The drug, which is taken as a tablet twice a day, has been shown to reduce the rate of hospitalization and cardiovascular death due to heart failure.

In a large trial called PARADIGM, which included more than 8,000 patients, half of the participants were treated with Entresto and half with another drug called enalapril. The majority of patients were also already taking current therapies for heart failure such as diuretics, beta-blockers and mineralocorticoid antagonists. The results showed that those given Entresto had a 20% reduction in risk of hospitalization or cardiovascular death.

Pavel Ignatov / Shutterstock.com

The new drug was reviewed under the FDA’s “priority review program,” which expedites the review of drugs that may be able to treat a serious or life threatening condition and offer significant benefits over currently available therapies. Entresto has also been granted “fast track designation,” which supports the FDA’s effort to accelerate the review of drugs that may treat high-risk patients and fill an unmet medical need.

The most common side effects associated with Entresto were high blood potassium, low blood pressure and renal impairment. An allergic reaction referred to as angioedema, where the face or lips swell, was also experienced by some patients. Healthcare professionals are advising that Entresto should not be used with ACE (angiotensin converting enzyme) inhibitors because this increases the risk of angioedema. Patients should wait for 36 hours after stopping the use of an ACE inhibitor before they switch to Entrestro.

Entresto is made up of two components: valsartan and sacubitril. Valsartan is the same active ingredient found in the drug Diovan, which has already been approved for the treatment of high blood pressure and heart failure. It works by enhancing protective neurohormonal systems in the body. Sacubitril inhibits the enzyme neprilysin and is thought to stop the damaging effects of a hormonal system that controls fluid balance and blood pressure.

Entrestro will now be available to patients who have class II-IV chronic heart failure and reduced ejection fraction, which represents about 2.2 million of the 5.1 million people suffering from heart failure in the U.S.