Novartis 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..."
AHF is a life-threatening medical condition and is the leading cause of hospitalization in those over 65 years old.