Actelion Ltd today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for selexipag (Uptravi) for the treatment of patients with pulmonary arterial hypertension (PAH).

Selexipag, the first selective oral IP prostacyclin receptor agonist, was studied in the pivotal Phase III GRIPHON study in 1,156 patients with pulmonary arterial hypertension (PAH). As reported in June 2014, the study demonstrated that selexipag decreased the risk of a morbidity/mortality event versus placebo by 39% (p<0.0001). Efficacy observed was consistent across the key subgroups; age, gender, WHO Functional Class, PAH etiology and background PAH therapy. Patients were treated for up to 4.2 years. The overall tolerability profile of selexipag in GRIPHON was consistent with prostacyclin therapies. Adverse reactions occurring more frequently (>5%) on selexipag compared to placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "Successfully submitting the selexipag NDA dossier to the FDA is another great milestone for us at Actelion, and a great way to mark the end of a remarkable year for us all. With the submission process underway for selexipag with both the FDA and EMA, I am looking forward to 2015 and to continuing to work with health authorities to move forward with these submissions in order to make selexipag available to the PAH community at the earliest opportunity."

For more details, go to: http://www1.actelion.com/en/our-company/news-and-events.page?newsId=1883059&bb=js