Novartis granted Breakthrough Therapy for acute heart failure drug

The US FDA has granted Breakthrough Therapy designation to Novartis’ investigational treatment for acute heart failure, serelaxin (RLX030).

The FDA came to this decision after considering the available clinical evidence which supports a substantial improvement over currently available therapies for the life-threatening illness, acute heart failure (AHF). A phase 3 clinical trial found 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.

“RLX030 is representative of Novartis’ strong commitment to develop innovative treatments for patients in areas of significant unmet need. Commonly used medicines for AHF only improve the immediate symptoms, so the additional effect on survival observed with RLX030 offers hope to patients and physicians.”

David Epstein, Division Head of Novartis Pharmaceuticals.

Each year around 3.5 million AHF episodes happen in the US and the EU alone. There is an urgent need for new treatments that 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 health authorities around the world including the FDA and the European Medicines Agency (EMA) for the treatment of AHF.

 

Related news:

Novartis heart drug gets FDA’s ‘breakthrough’ status (Reuters)

Reference links:

Novartis press release

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