Novartis’ drug RELAX-AHF – following the Nature

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Novartis‘ drug RELAX-AHF – following the Nature: FDA granted Breakthrough Therapy (BT) designation status, says Novartis.

AHF is an acute heart failure and, in this episode patients become severely breathless and incapacitated and may rapidly gain weight due to fluid build-up in the lungs and around the body. It is a potentially life threatening situation.

RLX030 (Serelaxin) is developed to address the above. RLX030 is an investigational treatment for patients with acute heart failure (AHF).  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. Acute Heart Failure is a life-threatening illness.  RELAX-AHF Phase III trial 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 [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].

Human relaxin-2 is a naturally occurring hormone present in both Men and Women (Teichman S et al. Relaxin, a pleiotropic vasodilator for the treatment of heart failure. Heart Fail Rev. 2009;14:321-329) and more so in pregnant women to meet the extra-demand during the pregnancy period (Teichman SL et al. Relaxin: Review of biology and potential role in treating heart failure. Curr Heart Fail Rep. 2010;7:75-82.).

RLX030 (serelaxin) developed by Novartis is a form of this naturally occurring human relaxin-2. RLX030 is proposed for administration on admission to the emergency room to patients experiencing an AHF episode and is infused over a 48 hour period, in addition to conventional therapies.

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