FDA approves Entresto (sacubitril/valsartan) for treatment of heart failure- Novartis

Novartis has announced that the FDA has approved Entresto (sacubitril/valsartan) tablets, previously known as LCZ 696, for the treatment of heart failure with reduced ejection fraction. 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 hospitalization. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.

The FDA's decision is 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, patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. 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.