Actelion announces Tracleer approved for use in EU

Tracleer (bosentan) has been approved for use in the European Union (EU) to treat patients with mildly symptomatic pulmonary arterial hypertension (PAH WHO functional class FC II).

Tracleer is already approved for use in the EU for PAH patients with WHO FC III.

This is the first time a clinical study has looked exclusively at treatment for patients with mildly symptomatic WHO FC II.

Jean-Paul Clozel, managing director and chief executive officer at Actelion, said: “I am very proud that Actelion ? together with the scientific community ? has been able to demonstrate the important role of Tracleer in delaying disease progression in these patients.”

The study found pulmonary vascular resistance improved significantly, with a decrease of 22.6 per cent after six months of Tracleer compared with placebo.

Exercise capacity measured by a six-minute walk test also increased by a mean of 19 metres.

Furthermore, a 77 per cent risk reduction in clinical worsening was recorded after six months of treatment with the drug.

The study found safety and tolerability of Tracleer was consistent with that observed in previous placebo-controlled trials.

Last month, Actelion entered into an exclusive collaboration with GlaxoSmithKline to investigate the full potential of almorexant in sleep disorders.