Actelion Receives Health Canada Approval of Opsumit for Long-Term Treatment of Pulmonary Arterial Hypertension

Actelion Pharmaceuticals Ltd ALIOF/ Actelion receives Health Canada approval of Opsumit (macitentan) for the long-term treatment of pulmonary arterial hypertension . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. ALLSCHWIL, SWITZERLAND - 12 NOVEMBER 2013 - Actelion Ltd ATLN announced today that Health Canada has granted a Notice of Compliance (NOC) approving the orally available endothelin receptor antagonist OpsumitTM (macitentan) 10 mg once daily for the treatment of pulmonary arterial hypertension (PAH). Opsumit (macitentan) is indicated in Canada, for the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group l) to reduce morbidity in patients of WHO Functional Class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease. Opsumit is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitors. Dr. Sanjay Mehta, MD, FRCPC, FCCP, Professor of Medicine at Western University, Director of the Southwest Ontario Pulmonary Hypertension Clinic at the London Health Sciences Center in London, Ontario and Chair of the Pulmonary Hypertension Association of Canada commented: "This new study represents a critical milestone in the treatment of PAH patients. We now have a new standard of excellence for clinical trials See full press release