Novartis announced Phase 3 study results of RLX030 (serelaxin) in patients with acute heart failure (AHF).
RELAX-AHF was a six-month, randomized, double-blind, placebo-controlled study involving 1,161 patients in 11 countries. In the study, RLX030 was given on admission to the hospital in the form of an intravenous infusion for up to 48 hours in addition to loop diuretics and other medicines and was compared to placebo on top of standard of care treatment for AHF.
The study showed that RLX030 reduced all-cause mortality. The study had two primary endpoints using different scales to measure reduction in dyspnea, only one of which reached statistical significance.
RLX030 is a recombinant form of the human hormone relaxin-2 which occurs naturally in both men and women. In women, levels of relaxin-2 rise to support important physiological changes during pregnancy. Serelaxin acts by relaxing the blood vessels, leading to reduced stress on the heart and kidneys in both men and women.
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