EC approves Actelion's Opsumit for PAH

The European Commission approved an MAA from Actelion Ltd. (SIX:ATLN) for Opsumit macitentan as monotherapy or in combination with phosphodiesterase-5 ( PDE5) inhibitors or prostacyclin to treat pulmonary arterial hypertension in adults. Actelion plans to launch the tissue-targeting endothelin receptor antagonist in Germany in February. Opsumit is also approved in the U.S. and Canada to treat PAH. The drug is under review in Switzerland, Australia, Taiwan, Mexico, South Korea and Israel. ...