Novartis has received approval from Swissmedic for Entresto (sacubitril/valsartan), which reduces the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction (HFrEF).
Entresto is a twice-a-day tablet that reduces the strain on the failing heart and it acts to improve the protective neurohormonal systems of the heart (NP system), while simultaneously suppressing the harmful system (the RAAS).
Previously known as LCZ696, the drug will be available on prescription for adults whose condition is classified NYHA class II-IV and with an ejection fraction of 40% or less.
The drug is administered in combination with other heart failure therapies as appropriate, in place of an ACE inhibitor or angiotensin receptor blocker.
Novartis Pharmaceuticals Division head David Epstein said: "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."
The company said that the Swissmedic approval allows other health authorities around the world to complete their review of Entresto.
The approval is based on results from the 8,442-patient PARADIGM-HF trial in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril.
The trial showed that patients treated with Entresto were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril.
In the PARADIGM-HF trial, a total of 8,442 patients showed that versus enalapril, Entresto reduced the risk of death from cardiovascular causes by 20%, heart failure hospitalisations by 21% and the risk of all-cause mortality by 16%.
In August, Novartis signed an agreement with GlaxoSmithKline (GSK) to buy all remaining rights of Ofatumumab for around $1bn.
Ofatumumab is a fully human monoclonal antibody that targets CD20 being developed to treat relapsing remitting multiple sclerosis (RRMS) and other autoimmune indications.
