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

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The FINANCIAL — Novartis announced on September 18 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, according to Novartis.

“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 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.

Approximately 150,000 people in Switzerland live with heart failure and about half have the reduced ejection fraction form. Heart failure is a debilitating, life-threatening condition in which the heart cannot pump enough blood around the body. Patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention significantly impacting their quality of life.


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