Updated on 24 June 2013
Good news for acute heart failure (AHF) patients - US FDA grants breakthrough therapy designation to Novartis RLX030 (serelaxin)
Singapore: The US FDA granted breakthrough therapy designation status to Novartis RLX030 (serelaxin), an investigational treatment for patients with acute heart failure (AHF), as it substantially improves 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 RLX030 had a 37 percent reduction in mortality at six months after an acute heart failure episode as compared to those who received conventional treatment.
Dr David Epstein, division head, Novartis Pharmaceuticals, said that, "RLX030 is representative of Novartis` strong commitment to develop innovative treatments for patients in areas of significant unmet need. Commonly used medicines for AHF only improve the immediate symptoms, so the additional effect on survival observed with RLX030 offers hope to patients and physicians."
RLX030 is currently being assessed by health authorities around the world including the FDA and the European Medicines Agency (EMA) for the treatment of AHF.
RLX030 (serelaxin) is a form of a naturally occurring hormone (human relaxin-2), present in both men and women, although its levels rise in pregnant women to help the body cope with the additional cardiovascular demands during pregnancy.