You are here
Heart Drug Serelaxin Gets ‘Breakthrough’ Status
The FDA has granted “breakthrough therapy” status to serelaxin (RLX030, Novartis), an investigational treatment for patients with acute heart failure (AHF). The agency concluded that serelaxin qualifies for the designation after considering the available clinical evidence, which indicates substantial improvement over currently available therapies for AHF, a life-threatening illness.
The FDA’s decision was supported by efficacy and safety results from the phase III RELAX-AHF trial, which also showed that patients who received serelaxin had a 37% reduction in mortality at 6 months after an AHF episode compared with those who received conventional treatment.
Each year, approximately 3.5 million AHF episodes occur in the U.S. and Europe; this is expected to increase further as the population ages. Every AHF episode contributes to worsening heart failure and damage to vital organs, such as the heart and kidneys, which decreases the chance of the patient surviving another episode. New treatments are needed that help relieve patients’ symptoms and protect vital organs against damage during an AHF episode, and that have the potential to increase life expectancy in the AHF patient population.
Serelaxin (RLX030) is a form of a naturally occurring hormone (human relaxin-2) that is present in both men and women, although its levels rise in pregnant women to help the body cope with the additional cardiovascular demands during pregnancy. The drug is proposed for administration on admission to the emergency room to patients experiencing an AHF episode and is infused over a 48-hour period, in addition to conventional therapies.
In the RELAX-AHF trial, serelaxin was shown to have both short and longer-term effects, helping patients breathe during and after an AHF episode, and reducing the rate of heart failure worsening.
Source: Novartis; June 21, 2013.