New data revealing the reduction in cardiovascular (CV) deaths with Novartis’ LCZ696 in patients with heart failure with reduced ejection fraction (HF-REF) will be presented at the European Society of Cardiology (ESC) Congress 2014. The study met the primary endpoint showing LCZ696 reduced heart failure hospitalisations along with CV deaths.
The 8,442 patient study, PARADIGM-HF, was specifically designed to see if LCZ696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients. In March 2014 the Data Monitoring Committee overseeing the study confirmed those given LCZ696 were significantly less likely to die from CV causes, leading to the trial being closed early.
Over 26 million people worldwide live with heart failure, facing a high risk of death and poor quality of life, despite currently available medicines. As a serious condition with an urgent need for new treatments, the FDA has granted LCZ696 Fast Track designation, which can expedite the review of new medicines intended to treat serious or life-threatening conditions. Fast Track designation also allows for rolling submission in the US, which Novartis expects to complete by the end of 2014.
The scientific presentation at the ESC Congress 2014 will include safety data from the study showing LCZ696 was well-tolerated and side effects manageable. 10 further presentations throughout ESC Congress 2014 will provide a wider overview of Novartis’s ongoing research in heart failure and other areas of cardiology.
EP News Bureau- Mumbai