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22 Sep 2015

Swissmedic approves Novartis' new heart failure medicine Entresto

Decision by Swiss Health Authority follows FDA approval of Entresto in July, and serves as an important reference approval for multiple other health authorities.

Novartis has 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.

"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. Swissmedic's decision is based on results from the 8442-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.

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