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Novartis phase III study shows RLX030 improved symptoms and reduced deaths by one-third in patients with acute heart failure

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The phase III RELAX-AHF study has shown that investigational RLX030 (serelaxin) improved symptoms and reduced deaths by one-third at the end of six months in patients with acute heart failure (AHF). Most of these deaths were due to cardiovascular causes. RLX030 is the first in a new class of medicines and is believed to act through multiple mechanisms on the heart, kidneys and blood vessels.

RELAX-AHF demonstrated that RLX030 significantly reduced dyspnea (i.e. shortness of breath), the most common symptom of AHF and the primary endpoint of the study. As one of two co-primary endpoints was met, the study achieved its primary objective based on pre-specified protocol criteria.

Results of the study were presented at the American Heart Association (AHA) Scientific Sessions in Los Angeles and published simultaneously in The Lancet.

“This study with serelaxin is important because it may offer the prospect of a much-needed new medicine for acute heart failure, where the death rate remains high and there have been few new therapies for several decades,” said Professor John R Teerlink of the Section of Cardiology, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, the co-lead investigator of the RELAX-AHF study.

Professor Marco Metra, Director of the Institute of Cardiology at the University and Civil Hospital of Brescia, Italy, the other co-lead investigator of the study, said: “The reduction in mortality seen with serelaxin is supported by the decreases in episodes of worsening of heart failure, as well as by the biomarker data collected during the study, suggesting that the clinical effects of serelaxin may be linked to a beneficial effect on organs such as the heart and kidneys.”

Novartis has begun discussing the results of this single phase III study with health authorities worldwide.

Tim Wright, Global Head of Development, Novartis Pharma said, “The survival results with RLX030 are encouraging for patients, their families and society at large. Novartis is committed to significantly improving treatment outcomes for patients with heart failure, and these results support our research into this therapeutic area which may lead to better management of the disease.”

EP News Bureau

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