Swiss drugmaker Novartis AG (NVS: Quote) 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 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 addition of RLX030 to conventional treatment led to improvements in breathlessness and mortality at 6 months across all pre-specified subgroups including those with renal impairment, the elderly and patients with atrial fibrillation, although the small numbers of patients in each group limit the statistical conclusions that can be drawn.
Novartis said AHF patients require urgent treatment and that prompt decision-making to stop heart failure worsening is crucial in spite of patients often having diverse clinical profiles.
RLX030 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.
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by RTT Staff Writer
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