Actelion files MAA at EMA for Uptravi (selexipag) for treatment of PAH

Actelion Ltd announced the submission of a centralized Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Uptravi (selexipag) in the treatment of Pulmonary Arterial Hypertension (PAH). The application is now pending validation. Submissions to the FDA 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 with PAH. The GRIPHON study, as reported in June 2014, demonstrated that selexipag decreased the risk of a morbidity/mortality event versus placebo by 39% (p<0.0001). Efficacy observed was consistent across key subgroups: age, gender, WHO Functional Class, PAH aetiology 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.