Japanese approval for Bayer's riociguat for CTEPH

German pharma major Bayer (BAYN: DE) has received approval from the Ministry of Health, Labor and Welfare (MHLW) for riociguat, trade name Adempas, for the treatment of adults with inoperable chronic-thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment by) in Japan.

The MHLW granted an orphan drug designation for riociguat in the CTEPH indication in September 2011. The US Food and Drug Administration approved Adempas to treat adults with two forms of pulmonary hypertension last fall: CTRPH and pulmonary arterial hypertension of unknown causes, inherited or associated with connective tissue diseases (The Pharma Letter October 9). The drug is under review at the European Medicines Agency.

The drug will join a PAH market expected to grow to a value of $3.57 billion by 2015, according to GlobalData. The current market is dominated by Tracleer (bosentan) – due to lose patent protection in 2015 - from Switzerland’s Actelion. Riociguat could generate $498 million in sales by 2017, according to the average of six analysts’ estimates compiled by Bloomberg.