Actelion announces benefit of Tracleer in PAH patients

Actelion has announced the publication of new data in the Lancet for Tracleer (bosentan) in patients with mildly symptomatic pulmonary arterial hypertension (PAH).

In the Early study the compound prevented clinical deterioration in WHO functional class II (WHO FC II) patients, with a significant delay in time to clinical worsening.

There was also a reduction in the number of patients worsening to WHO FC III and IV, with researchers also observing a positive trend in increasing 6MWD and pulmonary vascular resistance.

Actelion notes that it is currently working in conjunction with the regulatory authorities in Europe and the US to expand the label for Tracleer as to include WHO FC II as an approved indication.

Tracleer is an orally-administered dual endothelin receptor antagonist currently licensed for the treatment of PAH.

Professor Gerald Simonneau, of the Hopital Antoine Beclere, at Universite Paris-Sud, France, said: “The results from Early show the relentlessly progressive nature of PAH, even in its early stages.

“It is of paramount importance to screen high risk patients to attain a timely diagnosis and then to treat these patients with an evidence-based approach.”

He added that it is vital for PAH patients in all function class to be monitored routinely for the earliest signs of progression in their condition.

In September 2007, Actelion announced the results of a phase IIIb clinical trial of Tracleer showing the need for early diagnosis and treatment of PAH.