Swiss pharmaceutical firm Actelion Ltd. (ALIOF.PK) Monday said it has submitted a New Drug Application or NDA to the US Food and Drug Administration, seeking approval for macitentan or Opsumit, for the treatment of patients with pulmonary arterial hypertension. Macitentan is a novel oral dual endothelin receptor antagonist.
Macitentan was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN. In the study, 742 patients suffering from pulmonary arterial hypertension were randomized to receive placebo or macitentan at 3 mg or 10 mg once daily. Treatment with macitentan demonstrated a reduction in the risk of morbidity and mortality event over the treatment period compared to placebo.
This risk was reduced by 45 percent for patients in the 10 mg dose group and was reduced by 30 percent for patients receiving the 3 mg dose.
Patients in SERAPHIN were treated for up to three and a half years and safety data showed that macitentan was well tolerated. The most common adverse events were nasopharyngitis, headache and anemia.
Jean-Paul Clozel, Chief Executive Officer of Actelion, said, "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"
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