Japan OKs Actelion's Tracleer for PAH

Swiss drugmaker Actelion says that the Japanese Ministry of Health, Labor and Welfare has granted formal approval for its oral dual endothelin receptor antagonist Tracleer (bosentan) for the treatment of all forms of pulmonary arterial hypertension.

The group is in discussions with reimbursement authorities to finalize pricing, and expects to introduce the drug, which has a peak sales forecast of $400.0-$500.0 million for the PAH indication alone, in Japan by early June 2005.

Satoshi Tanaka, president of Actelion Japan, noted: "since its first market introduction in late-2001, Tracleer has revolutionized the treatment of PAH, a serious and life-threatening disease."