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FDA Grants Breakthrough Therapy Designation To Novartis AG's Serelaxin (RLX030) For Acute Heart Failure


Friday, 21 Jun 2013 01:25am EDT 

Novartis AG announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to RLX030 (serelaxin), an investigational treatment for patients with acute heart failure (AHF). The FDA has concluded that RLX030 qualifies for a Breakthrough Therapy designation after considering the available clinical evidence which supports a substantial improvement over currently available therapies for AHF 3, a life-threatening illness. 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% reduction in mortality at 6 months after an acute heart failure episode compared to those who received conventional treatment. 

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