Bayer Healthcare announced the submission of a New Drug Application to the FDA for riociguat for the treatment of pulmonary arterial hypertension (PAH) and persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH. Riociguat (BAY 63-2521) is an oral soluble guanylate cyclase (sGC) stimulator being studied in CTEPH, and PAH, as well as other forms of pulmonary hypertension.
The NDA submission is supported by data from two global Phase 3 studies of riociguat CHEST–1 and PATENT–1. The primary endpoint for both CHEST–1 and PATENT–1 was improvement in 6–minute walking distance. Both Phase 3 studies on riociguat met their primary endpoint.
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