Serelaxin for AHF gets breakthrough-therapy designation through FDANews - June 24, 2013
This means that the novel recombinant form of human relaxin 2, also known as RLX030, likely faces a speedier regulatory path through the US approval process, after considering the available clinical evidence supporting a potentially substantial improvement over currently available therapies for AHF.
The FDA’s decision was supported by efficacy and safety results from the phase III RELAX-AHF trial, which also showed that patients who received serelaxin had a 37% reduction in mortality at 6 months after the acute heart failure episode compared to those who received conventional treatment .
Serelaxin reduced shortness of breath as assessed using one of two dyspnea end points and appeared to reduce signs and symptoms of congestion and worsening heart failure.
Breakthrough therapy designation is reserved for the development or review of drugs seen as potential game changers for serious and life-threatening conditions that have preliminary evidence indicating improvement in at least one clinically significant end point over other available therapies.
1. Novartis. FDA grants breakthrough-therapy designation to Novartis' serelaxin (RLX030) for acute heart failure [press release]. June 21, 2013. Available here.
2. Teerlink et al. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet, 2013;381:29-39.