Actelion Wins European Approval for Pulmonary Arterial Hypertension Drug
Posted on: Tuesday, 5 August 2008, 06:00 CDT
Actelion has announced that Tracleer, a dual endothelin receptor antagonist, has been approved in the European Union for the treatment of patients with mildly symptomatic pulmonary arterial hypertension.
Tracleer is claimed to be the first pulmonary arterial hypertension (PAH) treatment ever to be investigated in a clinical study that exclusively enrolled patients with mildly symptomatic pulmonary arterial hypertension. This 185-patient randomized, double-blind, placebo-controlled study called EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) provided the basis for this EU approval.
Jean-Paul Clozel, CEO of Actelion, said: "Our dual endothelin receptor antagonist Tracleer is the only PAH medicine to have demonstrated a delay in disease progression in three independent placebo-controlled, randomized clinical studies. Actelion will now communicate these important clinical findings to encourage early diagnosis and intervention."
Source: Datamonitor
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