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Novartis’ heart failure medicine Entresto receives FDA approval

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The Food and Drug Administration (FDA) US has stamped its seal of approval on Novartis’ heart failure medicine dubbed Entresto.

Available to patients whose condition is classified NYHA class II-IV through prescription, Entresto reduces the risk of cardiovascular death and heart failure hospitalization. The drug is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.

David Epstein, Division Head, Novartis Pharmaceuticals, said that thanks to Entresto, millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital.

FDA approved Novartis’ medicine based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril.

At the end of the study, patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

“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 US suffer from heart failure and about half have the reduced ejection fraction form. About 2.2 million of these patients have heart failure classified as NYHA II-IV, based on how much their symptoms limit their physical activity. Heart failure is a debilitating, 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 significantly impact quality of life.

Entresto is currently undergoing review by Health Authorities around the world, including in Canada, Switzerland and the EU. Once approved by health authorities around the world, Entresto could achieve estimated peak sales in excess of $5 billion for the reduced ejection fraction indication.