Novartis announced today that the Data Monitoring Committee (DMC) unanimously recommended early closure of the PARADIGM-HF study, indicating patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial will now close early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable.
LCZ696 is a combination of Diovan (an off-patent ARB that was formerly a blockbuster for hypertension) and AHU-377, a novel neprilysin inhibitor. This combination has the potential to move the needle, even for a company as large as NVS.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”