Entresto, earlier known as LCZ696, will be available to treat adult patients with symptomatic chronic heart failure and reduced ejection fraction (HfrEF) after final approval from the European Commission (EC).
Novartis studied Entresto in the 8,442-patient PARADIGM-HF trial which was stopped early on strength of results that showed a 20% cut in cardiovascular deaths versus enalapril.
The company said at the end of the study patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure when compared to enalapril.
Entresto had a similar tolerability profile to enalapril. It acts to improve the protective neurohormonal systems of the heart and suppress the harmful system.
Novartis said only few patients on Entresto discontinued trial medication for any adverse event compared with enalapril.
Novartis Pharmaceuticals division head David Epstein said: "With the poor prognosis heart failure patients face – only half will be alive 5 years from diagnosis – the CHMP’s endorsement of Entresto brings hope for HFrEF patients in Europe.
"Already we’re hearing about the benefits US doctors and HFrEF patients are experiencing with Entresto and hope to receive a final green-light from the EC soon."
About10,000 Europeans are diagnosed with heart failure every day and 15 million currently live with the condition, resulting a high risk of death and poor quality of life.