Source: DGNews  |  Posted 3 years ago

NEW YORK -- August 6, 2008 -- The European Union (EU) has approved bosentan (Tracleer) for the treatment of patients with mildly symptomatic pulmonary arterial hypertension (PAH World Health Organization [WHO] functional class [FC] II).

The approval is based on the results from the Endothelin Antagonist Trial in Mildly Symptomatic PAH Patients (EARLY).

The randomised, double-blind, placebo-controlled study of 185 patients showed that pulmonary vascular resistance improved significantly, with a reduction of 22.6% (P < .0001) after 6 months compared with placebo.

A 77% risk reduction in time to clinical worsening (P = .011) was seen after 6 months compared with placebo. Patients receiving bosentan had a lower incidence of worsening functional class (3.4%) compared with placebo (13.2%).

The safety and tolerability profile of bosentan in the EARLY study was consistent with that observed in previous placebo-controlled clinical trials.

SOURCE: Actelion Ltd.