ARTICLE | Clinical News

Opsumit macitentan regulatory update

February 17, 2014 8:00 AM UTC

Actelion said Australia's Therapeutic Goods Administration ( TGA) and Swissmedic approved Opsumit macitentan as monotherapy or in combination therapy with phosphodiesterase-5 (PDE-5) inhibitors or inhaled prostanoids to treat pulmonary arterial hypertension (PAH). In Australia, the drug is indicated to treat 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. In Switzerland, Opsumit is indicated in PAH patients with WHO functional class II-III to reduce morbidity and the risk of mortality. The tissue-targeting endothelin receptor antagonist is approved in the EU, U.S. and Canada to treat PAH. The drug is under review in Taiwan, Mexico, South Korea and Israel. ...