European Commission (EC) has approved Switzerland-based Novartis’ Entresto tablets for treating adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
Entresto (sacubitril/valsartan) is a twice a day tablet for reducing the strain on the failing heart.
According to Novartis’ Tuesday announcement, the approval is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril.
To remind, Novartis n September announced approaching EC’s approval.
As for the study, it has shown that patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril.
“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,” said David Epstein, Division Head, Novartis Pharmaceuticals.