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Tracleer (bosentan) receives EU approval for pediatric formulation

The first and only licensed pulmonary arterial hypertension therapy for children

07-07-2009: Actelion Ltd announced that the pediatric dispersible formulation of Tracleer® (bosentan) for the treatment of pulmonary arterial hypertension (PAH) in children has been approved in the European Union.

This approval makes Tracleer® the only PAH therapy with an approved pediatric formulation for treating children from two years of age. PAH is a severe condition in children with an estimated median survival of 10 months after diagnosis if left untreated.

Isaac Kobrin, M.D. and Head of Clinical Development at Actelion, said: "Having the approval of Tracleer®, with an accurate dosing in a child-friendly form, is an important advancement in the treatment of PAH in children. After receiving approval in the EU, we will continue our regulatory filings in other countries to ensure that children can benefit from this pediatric formulation of Tracleer® on a worldwide basis."

Tracleer® is an oral, dual endothelin receptor antagonist, which is currently approved in Europe for the treatment of PAH; in WHO Functional Class III to improve exercise capacity and symptoms and in WHO Functional Class II where some improvements have also been shown. In the EU, Tracleer® is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.

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