23-Oct-2012 - Actelion Pharmaceuticals Ltd

Actelion submits a NDA for macitentan for the treatment of patients with pulmonary arterial hypertension

Actelion announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for macitentan (Opsumit®) 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.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "I am very pleased with the rapid progress the company has made in turning the outstanding clinical data into this submission, an important milestone for macitentan and indeed for Actelion. This brings us one step closer to our goal of delivering a new treatment option for patients with pulmonary arterial hypertension"

Facts, background information, dossiers
  • Actelion
  • New Drug Application
  • FDA
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