Bayer’s Riociguat submitted for regulatory approval in the U.S. and EU

12-Feb-2013 - Germany

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.

“These regulatory submissions for two distinct forms of pulmonary hypertension not only represent important progress in our cardiovascular pipeline but also fuel our hope to bring this much-needed new treatment option for these serious and potentially fatal diseases to patients and doctors soon,” said Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development.

Riociguat was discovered by Bayer and represents the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase (sGC). 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. In CHEST-1 patients treated with riociguat showed a statistically significant improvement (p<0.0001) from baseline in the six-minute walking test (6MWT) after 16 weeks, compared to those receiving placebo. The study included both patients with inoperable CTEPH and those with persistent or recurrent disease after a surgical procedure called pulmonary endarterectomy (PEA). The PATENT-1 study met its primary endpoint by demonstrating a statistically significant improvement (p<0.0001) from baseline in the 6MWT, after 12 weeks compared with placebo. PATENT-1 included both treatment naïve symptomatic PAH patients and those pre-treated with ERAs or non-iv prostanoid monotherapy.

https://www.bionity.com/en/news/141614/bayers-riociguat-submitted-for-regulatory-approval-in-the-u-s-and-eu.html