Novartis’ new heart failure medicine Entresto (sacubitril/valsartan) tablets, previously known as LCZ696, has been approved by the US Food and Drug Administration (FDA).

Entresto will be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalisation, said a statement.

It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker, it said.

David Epstein, division head, Novartis Pharmaceuticals, said: “Despite the uncertainty and high financial risk we designed the world’s largest heart failure trial to compare Entresto to the previous gold standard. As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital.

“We recognise our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week.”

The FDA’s decision was 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, the patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril. The analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

Dr Milton Packer, professor and chair for the department of Clinical Sciences at University of Texas Southwestern Medical Centre, Texas, said: “The very meaningful survival advantage of Entresto seen in the Paradigm-HF trial should persuadephysicians to consider Entresto forall appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers.

“Entresto is expected to change the management of patients with HFrEF for years to come.”

Nearly six million people in the US suffer from heart failure and about half have the reduced ejection fraction form, according to a report from the American Heart Association.

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, said another report.

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 hospitalisations 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, said the statement.

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, it added. - TradeArabia News Service