Bayer submits pulmonary hypertension drug for approval in U.S., EU

Bayer HealthCare has submitted the oral investigational drug riociguat to treat patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension for regulatory approval in the U.S. and in the European Union (EU).

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, according to the Berlin-based Bayer.

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.