Swissmedic approves Novartis’ new heart failure medicine Entresto

Novartis announced on September 18 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). 

Novartis says that 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.

 “This is another significant milestone and good news for HFrEF patients in Switzerland who will shortly be able to benefit from Entresto, helping them live longer and stay out of hospital”, said David Epstein, Division Head, Novartis Pharmaceuticals.

In July, Novartis announced that US Food and Drug Administration (FDA) had approved Entresto.

Novartis adds that Entresto has been undergoing review by Health Authorities around the world, including in Canada, and the EU.

Once approved by health authorities around the world, Entresto could achieve estimated peak sales in excess of $5 billion for the reduced ejection fraction indication, Novartis has concluded.