Actelion's PAH drug Opsumit gets Japan marketing nod, GSK's Encruse approved

Switzerland-based Actelion Pharmaceuticals was granted marketing approval by Japan's Ministry of Health, Labour and Welfare for Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH).

PAH is treatable by orphan therapies such as Tracleer (bosentan) by Actelion Pharmaceuticals and/or Bayer's novel drug Adempas (riociguat) for both inoperable chronic-thromboembolic pulmonary hypertension (CTEPH), and pulmonary arterial hypertension (PAH), or the generic forms of Pfizer's ($PFE) Viagra (sildenafil) or Eli Lilly's ($LLY) Cialis (tadalafil).

Also in Japan, GlaxoSmithKline ($GSK) said its Encruse Ellipta, an inhaler used to relieve airway obstruction symptoms associated with chronic obstructive pulmonary diseases, has been approved and it expects to launch the product there this year.

Glaxo said two acne products--Duac combination gel and Synflorix, have also gained Japanese approval.

- here's the release from Actelion (PDF)
- here's the release from GSK