Actelion announces Tracleer EU approval

Actelion has announced that Tracleer (bosentan) has received marketing approval from the European Commission as a treatment for new digital ulcers in systemic sclerosis patients with ongoing digital ulcer disease.

This approval follows the presentation of results from the Rapids-1 and Rapids-2 trials. The former trial investigated the prevention of ischemic digital ulcers in 122 patients through treatment with bosentan.

Rapids-2 – a key phase III clinical study – assessed the efficacy of besontan in preventing digital ulcers in patients with more serious forms of the condition, with these patients experiencing a 30 per cent drop in the number of new ulcers.

Tracleer is an orally-administered dual-endothelin receptor antagonist which has been approved as a treatment for pulmonary arterial hypertension in the European Union since May 2002.

“As vasculopathy is a pivotal feature of many of the complications of systemic sclerosis, patients suffering from the condition are at high risk to develop digital ulcerations and pulmonary arterial hypertension,” Actelion reports.

The company adds that half of all systemic sclerosis patients will experience digital ulcers as a result of their condition.

In March 2007, Actelion announced the positive results of a clinical trial assessing the use of Tracleer to reduce pulmonary vascular resistance in patients with inoperable chronic thromboembolic pulmonary hypertension.