Novartis Posts Topline Data For Heart Failure Drug

Novartis announced that new analyses from its late-stage study PARADIGM-HF showed that investigational treatment LCZ696 significantly changed the course of disease for heart failure patients.

LCZ696 is an Angiotensin Receptor Neprilysin Inhibitor (ARNI) believed to lower the amount of strain on a weak heart. The drug improves the levels of natriuretic and other endogenous vasoactive peptides while simultaneously hindering the renin-angiotensin-aldosterone system (RAAS).

The double blind, randomized, Phase 3 study PARADIGM-HF study investigated the safety and efficacy of LCZ696 against ACE inhibitor enalapril in patients with heart failure with reduced ejection fraction (HFrEF). Results show that compared to enalapril, LCZ696 cut the risk of sudden death, visits to the emergency room, hospitalization, worsening symptoms, and need for more intensive treatment in HFrEF patients. Observed effects on heart biomarkers, NTpro-BNP and troponin, indicate that LCZ696 also reduced cardiac stress and damage compared to enalapril.

David Epstein, Division Head of Novartis Pharmaceuticals, said, “These results provide strong evidence that we may be able to do more than reduce risk of death or hospitalization with LCZ696 versus enalapril. This therapy offers hope to millions of people living with HFrEF that they can also reduce or slow the decline in their heart function, potentially altering the progression of their disease.”

Earlier this year, Novartis also reported that LCZ696 reduced the risk of cardiovascular deaths by 20 percent of patient subgroups in the study. Up to half of those who die of cardiovascular events succumb when their heart stops beating before medical intervention reaches them.

Novartis presented the results of the new analyses at the American Heart Association Scientific Sessions 2014. Concurrent with the presentation, the company published the trial data in the journal Circulation.

Novartis said it intends to file with the U.S. Food and Drug Administration (FDA) by the end of the year as well as plans to submit a Marketing Authorization Application (MAA) for LCZ696 in the EU in early 2015.