Actelion files NDA at FDA for Uptravi (selexipag ) as a treatment for PAH

Actelion Ltd announced that it has submitted a New Drug Application (NDA) to the 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.>