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news.Swiss drugmaker Novartis has revealed positive results from its Phase III PARADIGM-HF trial of its LCZ696 drug in patients with heart failure with reduced ejection fraction (HF-REF).
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LCZ696 is a twice a day tablet being investigated for heart failure and is indicated to reduce the strain on the failing heart.
The company said that LCZ696 was superior to ACE-inhibitor enalapril on key endpoints in this heart failure study and the benefit of the drug that was seen early was sustained and consistent across subgroups.
During the trial, patients who were given LCZ696 were more likely to be alive and less likely to have been hospitalized for sudden deterioration of their heart failure compared to those given ACE-inhibitor enalapril.
Additionally, LCZ696 reduced the risk of death from cardiovascular causes by 20%, failure hospitalizations by 21% and the risk of all-cause mortality by 16%.
Novartis Pharmaceuticals division head David Epstein said by showing a very significant reduction in cardiovascular deaths while improving Quality of Life, the company’s new heart failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade.
"We want to thank leading cardiologists from around the world for their collaboration with us and their determination in advancing this important new life saving therapy for heart failure patients," Epstein said.
The drug helps in improving the protective neurohormonal systems of the heart (NP system) while suppressing the harmful system (the RAAS).
The Swiss firm intends to file the application for marketing authorization with the US Food and Drug Administration (FDA) by the end of 2014 and in the EU in early 2015.
Image: Novartis’ LCZ696 is a twice a day tablet being evaluated to treat heart failure. Photo: courtesy of Andrew.