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Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Date:2/11/2013

WAYNE, N.J., Feb. 11, 2013 /PRNewswire/ -- Bayer HealthCare today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for riociguat, an investigational compound for the treatment of pulmonary arterial hypertension (PAH) and persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH.

"Bayer is submitting an NDA for riociguat for the treatment of two distinct forms of pulmonary hypertension.  If approved, riociguat would be the first pharmacological treatment for CTEPH, and it would have the potential to add an important new treatment option to the armamentarium for PAH," said Pamela A. Cyrus , MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "The submission of riociguat is an important milestone in our cardio-pulmonary pipeline and is an example of Bayer's commitment to advancing treatment for hard to treat diseases."

The submission is supported by data from two global Phase III studies of riociguat CHEST-1 and PATENT-1.  Data from these two studies were presented in October 2012 at CHEST 2012, the annual meeting of the American College of Chest Physicians (ACCP).  Both Phase III studies on riociguat met their primary endpoint.

About CHEST
CHEST (Chronic Thromboembolic Pulmonary Hypertension sGC-Stimulator Trial) is a
Phase III trial to assess the efficacy and safety of oral riociguat in the treatment of patients with either inoperable CTEPH or CTEPH which has persisted or reoccurred after pulmonary endarterectomy (PEA). CHEST is a multi-center, multi-national program with active centers in 26 countries. The program includes a randomized, double-blinded, placebo-controlled trial phase (CHEST-1) and an open label extension trial phase (CHEST-2).

In the CHEST-1 study, 261 p
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SOURCE Bayer HealthCare
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