Actelion has announced the approval of Uptravi for the treatment of pulmonary arterial hypertension in Australia and New Zealand.
Actelion, Ltd, recently announced the approval of Uptravi (selexipag) by the Therapeutic Goods Administration (TGA) of Australia and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) for the treatment of pulmonary arterial hypertension (PAH).
Uptravi, an orally active selective IP prostacyclin receptor agonist, was approved to treat idiopathic PAH, heritable PAH, PAH associated with connective tissue disease, PAH associated with congenital heart disease with repaired shunts, and PAH associated with drugs and toxins, in patients with WHO functional class II, III, or IV symptoms.
The approval was partially based on the results of the Phase 3 GRIPHON trial, which were published in the New England Journal of Medicine in December 2015.
GRIPHON was a multicenter, double-blind, placebo-controlled trial evaluating the long-term efficacy and safety of oral selexipag in 1,156 patients with symptomatic PAH, and the largest study ever in PAH. The exposure to selexipag was up to 4.2 years and the mean duration of the treatment was 76.4 weeks for patients that received selexipag, versus 71.2 weeks for those on placebo. The findings established the effectiveness and safety of Uptravi in PAH patients with WHO functional class II-III symptoms.