- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Serelaxin Improves Symptoms and Mortality in Heart Failure Trial
Phase III data show benefits over 6 months (September 2)
Results from a new analysis of the phase III RELAX-AHF trial indicate that the investigational agent serelaxin (RLX030, Novartis) improved symptoms and mortality across subgroups of patients with acute heart failure (AHF). The new findings were presented at the European Society of Cardiology (ESC) congress in Amsterdam and were published in the European Heart Journal.
The addition of serelaxin to conventional treatment led to improvements in dyspnea and mortality at 6 months across all prespecified subgroups, including patients with renal impairment, the elderly (aged ≥ 75 years), and patients with atrial fibrillation, although the small numbers of patients in each group limited the statistical conclusions that could be drawn.
Serelaxin 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 additional cardiovascular demands during pregnancy.
In June 2013, the FDA granted serelaxin a Breakthrough Therapy designation.
Source: Novartis; September 2, 2013.