EU approves Entresto (sacubitril/valsartan) for adults with symptomatic chronic heart failure - Novartis

The European Commission has approved Entresto (sacubitril/valsartan), from Novartis, for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). 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. 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 than those given enalapril. Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or time to first heart failure hospitalization. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

Comment: Competitors are Reasanz (serelaxin) from Novartis which the FDA and the CHMP have rejected and a new trial RELAX-AHF 2 is to proceed. Finerenone from Bayer, a MRA antagonist with ongoing Phase II trial ARTS-HF study and Xarelto which showed a 60% benefit from an ACS trial in heart failure patients.