Swissmedic approves Novartis' new heart failure medicine Entresto(TM)

Decision by Swiss Health Authority follows US Food and Drug Administration (FDA) approval of Entresto in July, serves as an important reference approval for multiple other health authorities. Entresto is  indicated in Switzerland to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction -   People with heart failure face high risk of death and poor quality of life, with only half alive 5 years after diagnosis , Basel, September 18, 2015 - Novartis announced today that Swissmedic has approved Entresto(TM) (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. "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. As a key stage of Entresto manufacture happens in Switzerland and it is an important reference country for Novartis, the Swissmedic approval is particularly important as it enables multiple Health Authorities around the world to complete their review of Entresto.