European Commission approves Uptravi (selexipag) to treat pulmonary arterial hypertension.- Actelion

Actelion has announced that the European Commission has granted marketing authorization in the EU for the orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag) for the treatment of pulmonary arterial hypertension. Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

The EU label for Uptravi (originally discovered and synthesized by Nippon Shinyaku) was based in part on the Phase III GRIPHON study, whose main findings were published in the New England Journal of Medicine in December 2015. This placebo-controlled study, the largest ever in PAH, established the effectiveness, safety and tolerability of Uptravi in PAH patients with WHO Functional Class II-III.

Comment : First launch is likely to be in Germany.