SwissMedic approves Entresto (sacubitril/valsartan)to reduce CV risk in heart failure patients with reduced ejection fraction- Novartis

Novartis announced that Swissmedic has approved Entresto (sacubitril/valsartan), previously known as LCZ696, to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction (HFrEF). Entresto will be available on prescription for adult patients whose condition is classified NYHA class II-IV and with an ejection fraction of 40% or less. It is administered in combination with other heart failure therapies as appropriate, in place of an ACE inhibitor or angiotensin receptor blocker.

The Swissmedic approval is particularly important as it enables multiple health authorities around the world to complete their review of Entresto. Swissmedic's decision 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. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

Comment: Entresto was approved by the FDA on 7 July 2015. The MHRA in the UK has permitted early access to the drug to registered users for patients with heart failure with reduced ejection fraction, and EMA has granted an accelerated assessment with a decision due in 2015.