Actelion Ltd has received formal acceptance of the New Drug Application (NDA) for selexipag (Uptravi) by the US FDA.
The NDA dossier for selexipag (Uptravi) in the treatment of pulmonary arterial hypertension (PAH) was submitted to the FDA on the 22rdDecember 2014. Actelion expects results from the review process 12 months from the date of NDA submission.
The FDA application for selexipag (Uptravi), 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 (PAH).
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