NDA for Riociguat Granted Priority Review by FDA
Bayer Healthcare announced that the FDA has accepted its New Drug Application (NDA) for filing and has been granted priority review for its investigational compound riociguat (BAY 63-2521) for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent CTEPH after pulmonary endarterectomy (PEA) and pulmonary arterial hypertension (PAH). Riociguat is an investigational oral soluble guanylate cyclase (sGC) stimulator.
The NDA submission was supported by data from two global Phase 3 studies of riociguat, CHEST-1 (Chronic Thromboembolic Pulmonary Hypertension sGC-Stimulator Trial) and PATENT-1 (Pulmonary Arterial Hypertension sGC-Stimulator Trial). 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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