Actelion files Opsumit at FDA for treatment of PAH

Actelion has announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for macitentan Opsumit (macitentan)for the treatment of patients with Pulmonary Arterial Hypertension.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN, in which 742 patients suffering from pulmonary arterial hypertension were randomized to receive either placebo or macitentan at 3 mg or 10 mg once daily. Treatment with macitentan has demonstrated a reduction in the risk of morbidity and mortality event over the treatment period versus placebo. This risk was reduced by 45 percent for patients in the 10 mg dose group (p<0.0001). the observed risk reduction was 30 percent p="0.0108)" for patients receiving the 3 mg dose. patients in seraphin were treated for up to three and a half years providing safety data which showed that macitentan was well tolerated. the most common adverse events associated with the use of macitentan were nasopharyngitis headache and anemia.>