CHMP recommends Entresto (sacubitril/valsartan) to treat symptomatic chronic heart failure and reduced ejection fraction-Novartis

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Entresto (sacubitril/valsartan). Pending final approval by the European Commission, Entresto, previously known as LCZ 696, will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

The CHMP's decision, which follows previous US and Swiss approvals, is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown sacubitril/valsartan significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study patients who were given sacubitril/valsartan were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril. Analysis of safety data showed that sacubitril/valsartan had a similar tolerability profile to enalapril.

Comment: According to the UK's Early Access to Medicines scheme, sacubitril/valsartan has been shown to reduce mortality and hospital admissions by reducing the risk of cardiovascular mortality and morbidity in adult patients with symptomatic heart failure and reduced ejection fraction. Thus the MHRA has allowed Novartis to roll out the drug under the early-access scheme in the UK, even though it has not yet received EU approval.