Actelion gains approval in Australia for Opsumit in PAH

Swiss biotech firm Actelion (SIX: ATLN) has received approval of Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH) from the Therapeutic Goods Administration (TGA) of Australia.

Opsumit, as monotherapy or in combination with approved PAH treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of idiopathic and heritable PAH as well as PAH associated with connective tissue disease and PAH associated with congenital heart disease with repaired shunts in patients with WHO Functional class II,III or IV symptoms.

Jean-Paul Clozel, chief executive of Actelion, said: "This approval marks a significant moment for the PAH community in Australia as Opsumit is the first and only PAH treatment with proven long-term efficacy in controlled clinical trials in PAH, and will now offer hope of a better future to those living with this disease. Actelion is now working to make this important medicine available to patients around Australia in the coming months."