Opsumit approved to treat pulmonary arterial hypertension

The FDA has approved macitentan (Opsumit) to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating disease that can lead to death or lung transplantation. Opsumit belongs to a class of drugs called endothelin receptor blockers, which act to relax the pulmonary arteries, decreasing blood preasure in the lungs.

Opsumit’s safety and effectiveness were established in a long-term clinical trial in which 742 participants were randomly assigned to take Opsumit or placebo. The drug was effective in delaying disease progression, a finding that included a decline in exercise ability, worsening symptoms of PAH, or need for additional PAH medication.

Similar to members of its drug class, Opsumit carries a boxed warning alerting patients and healthcare professionals that the drug can harm a developing fetus and should not be used by pregnant women. Female patients can receive the drug only through the Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program. Common side effects are anemia, cold-like symptoms, sore throat, bronchitis, headache, flu, and urinary tract infection.

Actelion Pharmaceuticals Ltd. (650) 624.6900 www.actelion.us

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