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Entresto (Valsartan/Sacubitril) Wins FDA Nod for Heart Failure

Treatment reduces cardiovascular death, heart failure hospitalization versus enalapril

The FDA has approved Entresto (valsartan/sacubitril, Novartis) for the treatment of heart failure with reduced ejection fraction. The drug will be indicated to reduce the risk of cardiovascular death and heart failure hospitalization in patients whose condition is classified as New York Heart Association (NYHA) class II, III, or IV. It is usually administered in conjunction with other heart failure therapies in place of an angiotensin-converting enzyme (ACE) inhibitor or other angiotensin receptor blockers.

Entresto is a first-in-class medication (an angiotensin receptor/neprilysin inhibitor [ARNI]) that reduces the strain on the failing heart. Available as a twice-daily tablet, it enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful renin–angiotensin–aldosterone system (RAAS).

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 that may provide a significant improvement over available therapy. The treatment was also granted a “fast track” designation.

The FDA’s decision was based on results from the PARADIGM-HF study, which included 8,442 patients with heart failure. The study was stopped early when it was shown that Entresto significantly reduced the risk of cardiovascular death compared with the ACE inhibitor enalapril. Entresto reduced the risk of death from cardiovascular causes by 20%; reduced heart failure hospitalizations by 21%; and reduced the risk of all-cause mortality by 16%. Overall, there was a 20% risk reduction on the primary endpoint, a composite measure of cardiovascular death or the time to first heart failure hospitalization.

Fewer patients treated with Entresto discontinued the study medication because of an adverse event compared with those given enalapril. The Entresto group had more hypotension and nonserious angioedema but less renal impairment, hyperkalemia, and cough compared with the enalapril group.

Nearly 6 million people in the U.S. have heart failure, and about half have the form with reduced ejection fraction. About 2.2 million of these patients have heart failure classified as NYHA II–IV, based on the degree to which their symptoms limit their physical activity. Heart failure patients face a high risk of death and repeated hospitalizations, as well as symptoms that significantly affect their quality of life, such as breathlessness, fatigue, and fluid retention.

Sources: FDA; July 7, 2015; and Novartis; July 7, 2015.


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Decision supported by data from more than 4,000 patients