Swiss drugmaker Novartis AG (NVS) Monday said results from a new analysis of the Phase III RELAX-AHF study indicate that the investigational medicine RLX030 or serelaxin consistently improved symptoms and mortality across multiple subgroups of patients with acute heart failure or AHFassessed in the trial.
The addition of RLX030 to conventional treatment led to improvements in breathlessness and mortality at 6 months across all pre-specified subgroups. This includes those with renal impairment, old people and patients with atrial fibrillation.
RLX030 is a form of a naturally occurring hormone (human relaxin-2), present in men and women. Treatment of AHF is largely unchanged since the 1970s. With RLX030, Novartis aims to bring the first therapy shown to improve longer-term outcomes to patients.
Every year around 3.5 million AHF episodes happen in the US and EU alone. Novartis said AHF patients require urgent treatment and that prompt decision-making to stop heart failure worsening is crucial despite patients often having diverse clinical profiles.
According to the drugmaker, there is an urgent need for new treatments that help relieve patients' symptoms and protect the vital organs against damage during an AHF episode, and to increase life expectancy in the AHF patient population.
Results from RELAX-AHF presented in 2012 demonstrated that RLX030 reduced the risk of death by 37 percent compared with conventional treatment at six months. RLX030 is currently the only drug for
which a reduction in all-cause mortality has been observed in patients with AHF in a major study.
RELAX-AHF was an international randomized, double-blind study involving 1,161 patients. It was designed to compare the efficacy and safety profile of RLX030 to placebo in addition to standard therapy for the treatment of AHF.
RLX030 was given within 16 hours of hospitalization in the form of an intravenous infusion for 48 hours in addition to conventional therapy for AHF.
It is currently being assessed by health authorities around the world including the US Food and Drug Administration and the European Medicines Agency for the treatment of AHF.
In June, the FDA granted RLX030 Breakthrough Therapy designation status, recognizing its potential to address a serious unmet medical need.
David Epstein, Division Head of Novartis Pharmaceuticals, said, ''This new analysis adds to the overall results from RELAX-AHF that showed intervention with RLX030 is key to halting the downward spiral of organ damage that occurs during an AHF episode".
The results were published today in the European Heart Journal and presented as a late
breaker at the European Society of Cardiology congress in Amsterdam.
The stock is currently up 2.7 percent in Zurich at 69.70 Swiss francs.
by RTT Staff Writer
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