FDA approves Uptravi (selexipag) for the treatment of pulmonary arterial hypertension- Actelion

Actelion announced that the FDA has approved the use of the orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag), originally discovered and synthesised by Nippon Shinyaku, for the treatment of pulmonary arterial hypertension (PAH). Selexipag is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalisation.

Effectiveness was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), or PAH associated with congenital heart disease with repaired shunts (10%). The safety of selexipag was evaluated in a long-term, placebo-controlled study enrolling 1,156 patients with symptomatic PAH (GRIPHON study). The exposure to selexipag in this trial was up to 4.2 years with median duration of exposure of 1.4 years.

Comment: Approval for Uptravi will strengthen Actelion’s dominant position in PAH. In 2013, it received approval from FDA and EMA for Opsumit (macitentan), the follow-up to its successful drug Tracleer (bosentan).