FDA formally accepts Actelion's NDA for Uptravi

Switzerland-based Actelion (SIX: ATLN), Europe’s largest biotech company, says that the US Food and Drug Administration has formally accepted, with a standard review time, its New Drug Application for Uptravi (selexipag).

The NDA dossier for selexipag in the treatment of pulmonary arterial hypertension (PAH) was submitted to the FDA on the December 22, 2014. Actelion expects results from the review process 12 months from the date of NDA submission. Uptravi has also been filed for European approval.

The FDA application for selexipag, the first selective oral prostacyclin IP receptor agonist, is based on the findings of the positive pivotal Phase III GRIPHON study in 1,156 patients with pulmonary arterial hypertension.