New results for Novartis’ heart failure drug

New clinical trial results of Novartis' acute heart failure drug show that it consistently improved symptoms and mortality across multiple subgroups of patients.

The addition of RLX030 to conventional treatment led to improvements in breathlessness (dyspnea) 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.

Acute heart failure (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.

"Treatment of AHF is largely unchanged since the 1970s and with RLX030 Novartis aims to bring the first therapy shown to improve longer-term outcomes to patients. 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."

David Epstein, Division Head of Novartis Pharmaceuticals.

Every year, approximately 3.5 million AHF episodes happen in the US and EU alone. There is currently an urgent need for new treatments that can help relieve patients' symptoms and protect the vital organs against damage during an AHF episode, as well as have the potential to increase life expectancy in the AHF patient population.

RLX030 is currently being assessed by regulatory bodies around the world, including the FDA and EMA, for the treatment of AHF. The drug was granted Breakthrough Therapy designation status by the FDA back in June for its potential to address a serious unmet need.

These recent results were published in the European Heart Journal and presented at the European Society of Cardiology congress in Amsterdam.