Actelion submits selexipag for EMA marketing authorization in PAH

Swiss biotech firm Actelion (SIX: ATLN) has submitted a centralized Marketing Authorization Application to the European Medicines Agency for selexipag (Uptravi) in the treatment of pulmonary arterial hypertension (PAH).

The application 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 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.

Jean-Paul Clozel, chief executive of Actelion, said: “I am delighted that we have been able to submit this application in 2014, demonstrating once again the power of our commitment to bring forward new solutions for the PAH community as rapidly as possible. With selexipag, PAH specialists may be able to target the prostacyclin pathway with an oral therapy with long-term outcome benefits. We will work closely with Health Authorities in order to be able to make this treatment available to the PAH community as quickly as possible.”