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Opsumit (Macitentan) Gets FDA Nod for Treatment of Pulmonary Arterial Hypertension
Long-term treatment delays disease progression versus placebo (October 18)
The FDA has approved Opsumit (macitentan, Actelion Pharmaceuticals US, Inc.), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating disease that can lead to death or the need for lung transplantation.
Macitentan belongs to a class of drugs called endothelin receptor blockers, which act to relax the pulmonary arteries, thereby decreasing blood pressure in the lungs.
The safety and effectiveness of macitentan were established in a long-term clinical trial in which 742 participants were randomly assigned to treatment with macitentan or placebo. The average duration of therapy was approximately 2 years. In the study, macitentan was effective in delaying disease progression, a finding that included a decline in exercise ability, in worsening symptoms of PAH, or in the need for additional PAH medication.
Similar to other members of its drug class, the labeling for Opsumit (macitentan) includes a boxed warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Opsumit Risk Evaluation and Mitigation Strategy (REMS) program.
Common side effects observed in patients treated with macitentan include anemia, nasopharyngitis, sore throat, bronchitis, headache, flu, and urinary tract infections.
Source: FDA; October 18, 2013.