October 18, 2013
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FDA approves macitentan to treat PAH

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The FDA announced that it has approved macitentan, a dual endothelin-receptor antagonist, for the treatment of pulmonary arterial hypertension in adult patients.

The approval of macitentan (Opsumit, Actelion Pharmaceuticals) was based on results from the SERAPHIN trial of 742 people with PAH.

The primary endpoint of the SERAPHIN study was time from initiation to first occurrence of any of the following: death from any cause, atrial septostomy, lung transplantation, treatment with IV or subcutaneous prostanoids, or worsening of PAH. This endpoint occurred in 46.4% of patients assigned placebo, 38% of those assigned 3 mg macitentan and 31.4% of those assigned 10 mg macitentan. The HR for 3 mg macitentan compared with placebo was 0.7 (95% CI, 0.52-0.96). The HR for 10 mg macitentan compared with placebo was 0.55 (95% CI, 0.39-0.76).

Packaging for Opsumit will include a boxed warning contraindicating its use in pregnant women because of potential harm to the fetus, and the drug will only be distributed to women who enroll in a risk evaluation and mitigation strategy program, according to an FDA press release. Common adverse events observed in those taking macitentan include anemia, nasopharyngitis, sore throat, bronchitis, headache, flu and urinary tract infection.