Actelion receives Health Canada approval of Opsumit for PAH

Swiss biotech firm Actelion (SIX: ATLN) says that Canada’s regulator Health Canada has approved its endothelin receptor antagonist Opsumit (macitentan) 10mg once daily for the treatment of pulmonary arterial hypertension (PAH).

Opsumit is indicated in Canada for the long-term treatment of PAH to reduce morbidity in patients whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease. Opsumit is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitors. It is indicated to delay disease PAH progression, including death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.

Milestone for Actelion