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.”