Novartis' New Heart Drug Reduces Cardiovascular Deaths - Update

(RTTNews) - Swiss drug maker Novartis AG (NVS) said Saturday its investigational heart failure drug LCZ696 was found to be superior to enalapril on key endpoints in a heart failure study.

In the Paradigm-HF trial, LCZ696 cut cardiovascular deaths by 20 percent compared with enalapril. Enalapril is an angiotensin converting enzyme (ACE) inhibitor and is a widely prescribed generic drug to treat heart failure.

The LCZ696 trial involved about 8,400 patients and was specifically designed to see if the drug could decrease cardiovascular mortality by at least 15 percent compared with enalapril.

Results showed that LCZ696 reduced the risk of death from cardiovascular causes by 20 percent, lowered heart failure hospitalizations by 21 percent, and cut the ris of all-cause mortality by 16 percent.

LCZ696 is an Angiotensin Receptor Neprilysin Inhibitor and has a unique mode of action which is thought to reduce the strain on the failing heart. THe drug acts to enhance the protective neurohormonal systems of the heart while suppressing the harmful effects of the overactive renin-angiotensin-aldosterone system.

"By demonstrating a very significant reduction in cardiovascular deaths while improving quality of life, Novartis' new heart failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade," said David Epstein, division head, Novartis Pharmaceuticals.

Novartis plans to file the New Drug Application for review with the US Food And Drug Administration by the end of 2014.

The trial results were presented at the European Society of Cardiology conference in Barcelona, and the findings were also published online by the New England Journal of Medicine.