LONDON, Mar 22 (APM) - Novartis has suffered a setback with news on Wednesday that serelaxin for acute heart failure (AHF) failed a major three-and-a-half year Phase III study involving 6,600 patients.
RELAX-AHF-2 did not meet its primary endpoints of reduction in cardiovascular death through day 180 or reduced worsening heart failure through day five when added to standard therapy in patients with AHF, the Swiss pharma said in a statement.
Its chief medical officer Vas Narasimha said: "We are disappointed this study did not confirm the efficacy of RLX030 (serelaxin) in acute heart failure, especially given the urgent need for effective new treatments for this condition. We will continue to further analyse the data to better understand and learn from these results as well as evaluate next steps for the overall programme."
AHF is a life-threatening medical condition requiring urgent evaluation and treatment and is the leading cause of hospitalisation in those aged over 65 years. Risk of mortality after hospitalisation for AHF is high, with approximately one in five patients not surviving a year afterwards.
Serelaxin was rejected by European regulators in January 2014 (APMMA 37008) and by the U.S. in May that year, with the U.S. Food and Drug Administration saying it wanted further evidence of the drug's efficacy. (APMMA 38396)
RELAX-AHF-2 is an event-driven, multicentre, randomised, double-blind, placebo-controlled, Phase III trial designed to evaluate the efficacy, safety and tolerability of serelaxin when added to standard of care in patients with AHF.
The study has two primary endpoints: reduction of cardiovascular (CV) death through day 180 and occurrence of worsening heart failure through day five. The RELAX-AHF-2 study included 6,600 patients hospitalised for AHF and was initiated in October 2013.
Novartis has a marketed heart failure drug, Entresto (sacubitril+valsartan). In the fourth quarter of 2016, Entresto had $68 million of sales.
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