Novartis announced new data from the Phase 3 PARADIGM-HF study, in patients who received LCZ696 for heart failure with reduced ejection fraction (HFrEF).

PARADIGM-HF is a randomized, double-blind, outcome study evaluating the efficacy and safety profile of LCZ696 vs. enalapril in 8,436 patients with HFrEF. The primary outcome was a composite of time to first occurrence of either cardiovascular death or heart failure hospitalization. The trial is also designed to be able to detect a significant difference in cardiovascular death.

New analyses demonstrated that compared to enalapril, LCZ696 significantly reduced the risk of dying suddenly by 20%; in HFrEF patients, 45% of CV deaths and 36% of all-cause deaths were sudden. It also significantly reduced first and subsequent HFrEF hospitalizations by 21% and 23%, respectively, hospitalizations for a CV reason or for any reason both by 16%, the need for more intense outpatient treatment by 16%, and emergency room visits due to rapid symptom worsening by 30%. Analysis of cardiac biomarkers (NTpro-BNP and troponin) showed levels were consistently lower with LCZ696 vs. enalapril, reflecting reduced heart stress and subsequent damage.

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LCZ696 is the first in a new class of medicines called Angiotensin Receptor Neprilysin Inhibitors (ARNI) which act in multiple ways on the neurohormonal systems of the heart. LCZ696 blocks receptors exerting harmful effects while simultaneously promoting protective mechanisms. It is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover.

Novartis plans to submit a New Drug Application (NDA) for LCZ696 to the Food and Drug Administration (FDA) by the end of 2014.

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