Swiss drugmaker Novartis AG (NVS) Monday said the Data Monitoring Committee or DMC unanimously recommended early closure of the PARADIGM-HF study, indicating patients with chronic heart failure with reduced ejection fraction or 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, a twice a day pill for heart failure, is a first in class medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms.
The results of PARADIGM-HF will be submitted to a major medical conference for presentation. Novartis will now initiate discussions with global health authorities regarding approval for marketing.
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