Novartis' serelaxin fails Phase III acute heart failure test

Novartis AG (NYSE:NVS; SIX:NOVN) said serelaxin (RLX030) missed the primary endpoints in the Phase III RELAX-AHF-2 trial in patients with acute heart failure (AHF). Compared to placebo, serelaxin plus standard of care (SOC) did not reduce time to cardiovascular death through day 180 or time to worsening of heart failure through day five. The study included 6,600 patients.

In May 2014, FDA issued a complete response letter to a BLA for serelaxin to treat AHF, citing a need for further evidence of the candidate's efficacy. The letter followed a vote by an FDA advisory committee against approval of the recombinant human relaxin 2 (RLN2; H2) (see BioCentury, April 7, 2014 and BioCentury Extra, May 16, 2014)...