RLX 030 (serelaxin) fails to meet endpoints of reduction of cardiovascular death or worsening heart failure in RELAX-AHF-2.- Novartis
Novartis announced results from the global Phase III RELAX-AHF-2 study investigating the efficacy, safety and tolerability of RLX 030 (serelaxin) in patients with acute heart failure (AHF). 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.
AHF is a life-threatening medical condition requiring urgent evaluation and treatment, and is the leading cause of hospitalization in those aged over 65 years. Risk of mortality after hospitalization for AHF is high with approximately one in five patients not surviving a year afterwards.
Comment: In an 11-0 vote, the Cardiovascular and Renal Drugs Advisory Committee had rejected ,in 2014 , the Novartis' case for serelaxin, criticising the design of its 1,161-patient pivotal trial, gaps in the provided data and raised serious questions over serelaxin's efficacy. The EMA rejected the Novartis application in the same year.
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