BASEL (dpa-AFX) - Healthcare products major Novartis International AG (NVS) said that the US Food and Drug Administration or FDA has granted Breakthrough Therapy designation status to RLX030 or serelaxin, an investigational treatment for patients with acute heart failure or AHF. The FDA has concluded that RLX030 qualifies for a Breakthrough Therapy designation after considering the available evidence that supports a substantial improvement over currently available therapies for AHF, a life-threatening illness.
The FDA's decision was supported by efficacy and safety results from the phase III RELAX-AHF study, which demonstrated that patients who received RLX030 had a 37% reduction in mortality at 6 months after an acute heart failure episode compared to those who received conventional treatment.
'RLX030 is representative of Novartis' strong commitment to develop innovative treatments for patients in areas of significant unmet need,' according to David Epstein, Division Head of Novartis Pharmaceuticals.
RLX030, a form of a naturally occurring hormone present in both men and women, is currently being assessed by health authorities worldwide, including the FDA and the European Medicines Agency or EMA for AHF treatment.
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