Actelion submits selexipag (Uptravi) for EMA Marketing Authorisation in patients with pulmonary arterial hypertension (Actelion Ltd)

(Source: Actelion Ltd) ALLSCHWIL, SWITZERLAND - 02 December 2014 - Actelion Ltd (SIX: ATLN) today announced the submission of a centralized Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for selexipag (Uptravi®) in the treatment of pulmonary arterial hypertension (PAH). The application is now pending validation. Submissions to the US Food and Drug Administration and other territories are forthcoming. The application for selexipag, the first selective oral IP prostacyclin receptor agonist, is based on the positive findings of the pivotal Phase III GRIPHON study in 1,156 patients PAH. The GRIPHON study, as reported in June 2014, demonstrated that selexipag...