FDA approves new heart failure drug

July 8, 2015

The FDA this week approved Novartis’s sacubitril/valsartan (Entresto) tablets to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF).

FDA approved Novartis’s sacubitril/valsartan (Entresto) tablets to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF).

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“The approval of Entresto marks a new era in the treatment of heart failure, made possible by the collective efforts of our Novartis associates, the hundreds of cardiologists and nurses and thousands of patients who participated in the research,” said Christi Shaw, U.S. country head and president of Novartis Corporation and Novartis Pharmaceuticals Corporation. “We have so many people in the heart failure community to thank for helping bring this exciting new treatment to patients and are working hard to make it available at pharmacies as quickly as possible.”

FDA approval is based on results from the 8,442-patient PARADIGM-HF study, the largest clinical trial ever conducted in heart failure, according to Novartis. In the study, Entresto demonstrated clinically relevant and statistically significant superiority to ACE-inhibitor enalapril, reducing the risk of cardiovascular death or heart failure hospitalization by 20% (the primary end point) at a median follow-up of 27 months.

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Entresto also improved overall survival by 16% versus enalapril, driven by the lower incidence of cardiovascular death. The study was stopped early, after the Data Monitoring Committee overseeing the study found that Entresto significantly reduced the risk of cardiovascular death and that the primary end point had been met.

“The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers,” said Dr. Milton Packer, professor and chair of the Department of Clinical Sciences at University of Texas Southwestern Medical Center.

The drug is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB). Reduced ejection fraction means the heart doesn't contract with enough force, so less blood is pumped out.

Entresto film-coated tablets are available in 3 dosage strengths: 24/26 mg, 49/51 mg, and 97/103 mg (sacubitril/valsartan). These doses are referred to as 50 mg, 100 mg, and 200 mg in the clinical trial literature including the New England Journal of Medicine publication of the results of PARADIGM-HF. The target dose of Entresto is 97/103 mg twice daily.

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