Bayer files riociguat for CTEPH and Pulmonary Arterial Hypertension at FDA and EU

Bayer HealthCare has submitted the oral investigational drug riociguat to treat patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) for regulatory approval in the United States and in the European Union. Riociguat was discovered by Bayer and represents the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase. Riociguat is the first drug to demonstrate clinical efficacy in a placebo controlled phase III trial in inoperable CTEPH patients. The submission is supported by data from the two pivotal, global Phase III studies namely CHEST-1 and PATENT-1. Results of both studies were presented at the 2012 annual meeting of the American College of Chest Physicians in Atlanta, USA. Both Phase III studies on riociguat met their primary endpoint in exercise capacity. Riociguat was generally well tolerated, with no unexpected adverse events reported.