Actelion receives Health Canada approval of Opsumit
Actelion Ltd announced that Health Canada has granted a Notice of Compliance (NOC) approving the orally available endothelin receptor antagonist OpsumitTM(macitentan) 10 mg once daily for the treatment of pulmonary arterial hypertension (PAH).
Opsumit (macitentan) is indicated in Canada, for the long-term treatment of pulmonary arterial hypertension (PAH, 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.
Opsumit is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitors.
The most common adverse reactions observed with Opsumit (>3% compared to placebo) are nasopharyngitis, headache, anemia, bronchitis, urinary tract infection, pharyngitis and influenza.
It is recommended that hemoglobin concentrations are measured prior to initiation of treatment with Opsumit, again after one month, and periodically thereafter as clinically indicated. Liver enzyme tests should be obtained prior to initiation of Opsumit. Subsequently, monthly testing during the first year of treatment is recommended. They may then be repeated less frequently during treatment as clinically indicated.
Actelion expects Opsumitto become available to patients by early 2014 in Canada.
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