Results from a new analysis of the Phase III RELAX-AHF study published today in the European Heart Journal and presented as a late breaker at the European Society of Cardiology (ESC) congress in Amsterdam indicate that Swiss drug major Novartis’ (NOVN: VX) investigational agent serelaxin (RLX030) consistently improved symptoms and mortality across multiple subgroups of patients with acute heart failure (AHF) assessed in the trial.
The addition of RLX030 to conventional treatment led to improvements in breathlessness (dyspnea) and mortality at six months across all pre-specified subgroups including those with renal impairment (eGFR<50ml/min), the elderly (>=75 years) and patients with atrial fibrillation, although the small numbers of patients in each group limit the statistical conclusions that can be drawn. AHF patients require urgent treatment so prompt decision-making to stop heart failure worsening is crucial in spite of patients often having diverse clinical profiles.
Granted “Breakthrough” status by FDA
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