Novartis announces FDA approval of Entresto to reduce risk of cardiovascular death, heart failure hospitalization

Novartis announced today that the US Food and Drug Administration (FDA) has approved Entresto^™ (sacubitril/valsartan) tablets, previously known as LCZ696, 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). It 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.

“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, US Country Head, 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.”

The FDA’s decision is based on results from the 8,442-patient PARADIGM-HF study, the largest clinical trial ever conducted in heart failure. 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 endpoint) at a median follow-up of 27 months. 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 endpoint 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 for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA. “Entresto is expected to change the management of patients with HFrEF for years to come.”

Nearly 6 million people in the United States suffer from heart failure and about half have the reduced ejection fraction form. Up to 2.2 million of these patients have heart failure classified as NYHA II-IV, based on how much their symptoms limit physical activity. Heart failure is a debilitating and life-threatening condition in which the heart cannot pump enough blood around the body. Patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life.

“Heart failure places a tremendous physical, emotional and financial burden on patients, their caregivers and society,” said Michele Blair, Chief Executive Officer at the Heart Failure Society of America. “There is a great need in the heart failure community for therapies that improve patient outcomes. Today’s approval is a victory for patients, and we welcome the addition of a new treatment option to help manage this very serious condition.”