Monday, February 25, 2013

Novartis files Serelaxin for approval in Acute Heart Failure in Europe

The filing has been based on the Phase 3 RELAX-AF Study.  RELAX-AF was a randomized, double-blind study involving 1,161 patients and was designed to compare the efficacy and safety profile of RLX030, from Novartis, to placebo in addition to standard therapy for the treatment of Acute Heart Failure (AHF). RLX 030 was given upon hospitalization in the form of an intravenous infusion (30 mcg per kg per day) for 48 hours in addition to conventional therapy for AHF, i.e. loop diuretics and other medicines. The study has shown improved symptoms and reduced deaths by one-third at the end of six months in patients with AHF. Most of these deaths were due to cardiovascular causes.
RLX 030 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 RLX 030 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.

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