Health Canada has granted a notice of compliance approving Actelion's 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 (World Health Organization [WHO] Group l) to reduce morbidity in patients of WHO functional class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease.
This approval is based on positive safety and efficacy data from Phase III study, SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome). The most common adverse reactions observed with Opsumit (>3% compared with placebo) are nasopharyngitis, headache, anaemia, bronchitis, urinary tract infection, pharyngitis and influenza.
Actelion expects the product to become available to patients by early 2014 in Canada. The firm is continuing to work with other health authorities worldwide to obtain regulatory approvals for Opsumit.