Action receives approval for Uptravi (selexipag) for the treatment of pulmonary arterial hypertension in Australia and New Zealand

22 March 2016 - Actelion announced today that the Therapeutic Goods Administration (TGA) of Australia and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) have granted approval for the orally active selective IP prostacyclin receptor agonist Uptravi (selexipag) for the treatment of pulmonary arterial hypertension.

Uptravi is indicated for the treatment of 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.

Approval was granted by Medsafe on 17 March 2016 and by the TGA on 18 March 2016.

Simon Eade, Head of Actelion Asia Pacific Region, commented, "The approval of Uptravi represents a major step forward in disease management for the PAH communities in both Australia and New Zealand. Until now the options for treatments targeting the prostacyclin pathway have been limited, and were burdensome for the patient. Uptravi offers patients an oral treatment that targets the prostacyclin pathway, opening the way for oral combination therapies with proven long-term outcome benefits. We will now work to secure reimbursement and make Uptravi available to patients."

For more details, go to: http://www1.actelion.com/en/our-company/news-and-events.page?newsId=1996574&bb=js

Michael Wonder

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Michael Wonder