Actelion's Tracleer approved in EU for treatment of digital ulcers

Swiss biotechnology firm Actelion says that Tracleer (bosentan), its dual endothelin receptor antagonist, has been approved in the European Union for the reduction of the number of new digital ulcers (DUs) in patients with systemic sclerosis (SSc) and ongoing digital ulcer disease. Bosentan, the first drug indicated for the treatment of DUs, targets the underlying vasculopathy of the condition. Digital ulcers are a frequent, persistent and debilitating complication of SSc - approximately 50% of systemic sclerosis patients develop them and in many they represent a persistent and recurrent clinical problem. Bosentan is currently licensed for the treatment of pulmonary arterial hypertension (PAH Functional Class III in Europe, Class III and IV in the USA) to improve exercise ability.