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news.Novartis has secured approval from Swissmedic for its Entresto medicine, which reduces the strain on the failing heart.
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Entresto is indicated to lower the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction (HfrEF).
It improves the protective neurohormonal systems of the heart (NP system) and suppress the harmful system.
Swissmedic decision follows approval from the US Food and Drug Administration (FDA) in July.
Swissmedic’s approval was based on PARADIGM-HF study, under which 8,442 patients were treated with Entresto.
The study found that the medicine reduced the risk of cardiovascular death, when compared to ACE-inhibitor enalapril.
It also found that the risk of death from cardiovascular causes were reduced by 20%. The study said that the medicine lowered heart failure hospitalizations by 21% and reduced the risk of all-cause mortality by 16%.
Novartis said there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or time to first heart failure hospitalization.
Entresto is currently undergoing review by health authorities across the world, including in Canada and the EU.
Once approved by global health authorities, sales of Entresto are expected to cross $5bn for the reduced ejection fraction indication.
Commenting on Swissmedic’s approval, 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."
About 150,000 people in Switzerland live with heart failure and around half have the reduced ejection fraction form, the company said.
Image: Novartis headquarters in Basel. Photo: courtesy of –Andrew- from Flickr.