This favorable review from Japan’s Ministry of Health, Labour and Welfare (MHLW) follows a committee review meeting and will form the basis on which the Japanese government will issue the formal marketing authorization for Tracleer (bosentan) in the coming weeks.
Formal approval is expected in early April and Actelion expects that it could commercially launch the product in Japan in spring this year.
Tracleer is approved for the treatment of pulmonary arterial hypertension (PAH) and available in the US, the EU, Australia, Canada, Switzerland, Israel, Hong Kong, Malaysia, Singapore and Brazil, as well as several other smaller territories worldwide.
PAH is a life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs, which severely compromises the function of the heart and lungs.