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Actelion receives marketing approval for Opsumit (macitentan) in pulmonary arterial hypertension in Japan (Actelion Ltd)

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(Source: Actelion Ltd) ALLSCHWIL, SWITZERLAND - 26 March 2015 - Actelion (SIX: ATLN) announced today that Japan's Ministry of Health, Labor and Welfare granted marketing approval for Opsumit® (macitentan) for the treatment of pulmonary arterial hypertension (PAH). The approval was based on data from a local study conducted in Japan and the landmark global Phase III SERAPHIN study. In both studies, improvements in pulmonary vascular resistance, 6MWD, and WHO function class were observed. In the SERAPHIN study, treatment with macitentan 10 mg per day resulted in a 45% risk reduction (p Satoshi Tanaka, Dr. med Sci. President of Actelion Japan commented: "Opsumit represents a major step...

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