Novartis provides update on Phase III study of RLX030 (serelaxin) in patients with acute heart failure

Novartis International AG / Novartis provides update on Phase III study of RLX030 (serelaxin) in patients with acute heart failure . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Phase III RELAX-AHF-2 study did not meet primary endpoints of reduced cardiovascular death or worsening heart failure in patients with acute heart failure
   

Novartis remains committed to improving and extending the lives of patients with cardiovascular disease and will continue to invest in ways to improve their outcomes

Basel, March 22, 2017 - Novartis today announced results from the global Phase III RELAX-AHF-2 study investigating the efficacy, safety and tolerability of RLX030 (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.

"We are disappointed this study did not confirm the efficacy of RLX030 in acute heart failure, especially given the urgent need for effective new treatments for this condition," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "We will continue to further analyze the data to better understand and learn from these results as well as evaluate next steps for the overall program. Novartis would like to thank the patients, investigators, and site personnel around the world for their unwavering support of this study. We remain committed to improving and extending the lives of patients with cardiovascular disease and will continue to invest in ways to improve their outcomes." 

AHF is a life-threatening medical condition requiring urgent evaluation and treatment[1], and is the leading cause of hospitalization in those aged over 65 years[2],[3]. Risk of mortality after hospitalization for AHF is high[4]-[11] with approximately one in five patients not surviving a year afterwards[2],[12]-[14].

About RELAX-AHF-2
RELAX-AHF-2 (NCT01870778) is an event-driven, multicenter, randomized, double-blind, placebo-controlled, Phase III trial designed to evaluate the efficacy, safety and tolerability of RLX030 (serelaxin) when added to standard of care in patients with acute heart failure (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 hospitalized for AHF and was initiated in October 2013.