Actelion submits the registration dossier for macitentan to EMA
Actelion announced that the submission of the Marketing Authorisation Application (MAA) for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension to the EMA has been accepted. The EMA will now start the formal review process.
The United States Food and Drug Administration 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.
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.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "We have worked hard to prepare the dossiers for a timely submission to both Health Authorities and I am very happy that regulatory processes in both the United States and the European Union could be initiated. Actelion will continue to prepare for submissions in Switzerland and other major markets around the world."
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