"Breakthrough" status from FDA for Novartis' serelaxin (RLX030) for acute heart failure

The US Food and Drug Administration has granted Breakthrough Therapy designation status to RLX030 (serelaxin), an investigational drug for patients with acute heart failure (AHF), Swiss pharma major Novartis (NOVN: VX) announced this morning (June 21).

The FDA concluded that RLX030 qualifies for a Breakthrough status after considering the available clinical evidence which supports a substantial improvement over currently available therapies for AHF, a life-threatening illness, the company stated. The agency's decision was supported by efficacy and safety results from the Phase III RELAX-AHF trial, which also showed that patients who received RLX030 had a 37% reduction in mortality at six months after an acute heart failure episode compared to those who received conventional treatment.

Each year around 3.5 million AHF episodes happen in the USA and European Union alone; this is expected to increase further as the population ages. Every AHF episode contributes to a downward spiral of worsening heart failure and damage to vital organs, such as the heart and kidneys, which decreases the chance of the patient surviving another episode. 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.