Serelaxin: Ph III RELAX-AHF-2 data

Novartis reported top-line data from the double-blind, international Phase III RELAX-AHF-2 trial in 6,600 patients hospitalized for AHF showing that an IV infusion of serelaxin for 48 hours plus standard of care (SOC) missed the co-primary endpoints of reducing CV death through day 180 and of reducing the occurrence of worsening heart failure through day 5 vs. placebo plus SOC. In May 2014, FDA issued a complete response letter for a BLA for serelaxin to treat AHF, citing a need for further evidence of efficacy (see BioCentury, May 19, 2014). EMA’s CHMP has also recommended against serelaxin’s approval. Novartis said in 2014 that it planned to include data from RELAX-AHF-2 in resubmissions of regulatory applications for serelaxin (see BioCentury, May 26, 2014). The pharma said it will continue to analyze data from RELAX-AHF-2 and evaluate next steps...