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Pulmonary Hypertension Drug Riociguat Submitted for Agency Approval
A new drug application (NDA) has been submitted to the FDA seeking approval for riociguat (Bayer), 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.
The submission is supported by data from two global phase III studies of riociguat (the CHEST-1 and PATENT-1 trials). 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 trials of riociguat met their primary endpoints.
In the CHEST-1 study, 261 patients with inoperable CTEPH or with persistent or recurrent CTEPH after pulmonary endarterectomy (PEA) were randomly assigned to treatment with either riociguat or placebo for 16 weeks. In the PATENT-1 study, 445 patients with symptomatic PAH received two different doses of riociguat or placebo over 12 weeks. In both studies, the primary endpoint was improvement in the 6-minute walking distance.
Riociguat (BAY 63-2521) is an investigational oral soluble guanylate cyclase (sGC) stimulator that is being studied in CTEPH and PAH, as well as in other forms of pulmonary hypertension.
Source: Bayer; February 11, 2013.