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news.Actelion Ltd's Tracleer has received approval from the Japanese Ministry of Health, Labor and Welfare for all forms of pulmonary arterial hypertension, with a market launch expected in early June.
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Tracleer (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) (WHO class III and IV) and made available by Actelion subsidiaries in the US, the European Union, Australia, Canada, Switzerland, Israel, Hong Kong, Malaysia, Singapore and Brazil, as well as several other smaller territories worldwide.
“Actelion is very pleased that soon Japanese PAH patients will have access to our orally available dual endothelin receptor antagonist Tracleer,” commented Dr Satoshi Tanaka, president of Actelion Japan. “Since its first market introduction in late 2001, Tracleer has revolutionized the treatment of PAH, a serious and life-threatening disease.”
The company is currently in discussions with reimbursement authorities to finalize pricing before the drug’s expected launch in early June 2005.