The European Commission (EC) has approved Novartis' Entresto (sacubitril/valsartan) to treat adult patients with symptomatic chronic heart failure with reduced ejection fraction (HfrEF).
Subscribe to our email newsletter
Entresto was studied in a clinical trial of over 8,000 patients with HFrEF and was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to another drug, enalapril.
The data demonstrated that Entresto cut cardiovascular deaths by 20% versus enalapril, as well as heart failure hospitalisations and all-cause mortality by 21% and 16%, respectively.
Analysis of safety data demonstrated that Entresto had same tolerability profile to enalapril.
Entresto, a twice-a-day tablet, exhibits the mechanism of action of an angiotensin receptor neprilysin inhibitor that lowers the strain on the failing heart.
It acts to improve the protective neurohormonal systems of the heart and suppress the harmful system.
Novartis Pharmaceuticals division head David Epstein said: "We know that people living with heart failure face a high risk of death and have a worse quality of life than those with almost any other chronic condition, so it is very meaningful for HFrEF patients in Europe that we’re able to offer a new first in class treatment option."
Novartis said 10,000 Europeans are diagnosed with heart failure every day and 15 million are expected to live with the condition.
Entresto won an early approval in the US in July this year.
Image: Novartis headquarters in Basel. Photo: courtesy of –Andrew- from Flickr.