Actelion submits Opsumit to EMA for treatment of PAH

Actelion has announced that the submission of the Marketing Authorisation Application for macitentan (Opsumit) for the treatment of patients with Pulmonary Arterial Hypertension to the EMA has been accepted. The FDA had already received the registration dossier on October 22nd 2012.

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.>