Phase III data on LCZ 696 for Heart Failure published in Circulation-Novartis

Topline results from the Phase III PARADIGM-HF study show LCZ 696 (sacubitril + valsartan), from Novartis, was superior to ACE inhibitor enalapril for patients with Heart Failure on key endpoints, including significantly reducing the risk of cardiovascular (CV) death or heart failure hospitalization. In summary, the drug reduced the risk of dying suddenly by 20%. In patients with reduced ejection fraction (HFrEF), 45% of CV deaths and 36% of all-cause deaths were sudden. It reduced first and subsequent HFrEF hospitalizations by 21% and 23% respectively and reduced hospitalizations for a CV reason or for any reason both by 16%. Finally it reduced the need for more intense outpatient treatment by 16% and reduced emergency room visits because of rapid symptom worsening by 30%.

Data, which were announced in August, were presented at the American Heart Association Scientific Sessions 2014, with a paper being simultaneously published in Circulation. Novartis plans to complete the New Drug Application for LCZ 696 with the FDA by the end of 2014.