Actelion’ Tracleer Receives EU Approval For Pediatric Formulation

Actelion’ pediatric dispersible formulation of Tracleer (bosentan) for the treatment of pulmonary arterial hypertension (PAH) in children, has been approved in the EU.

Tracleer is an oral, dual endothelin receptor antagonist in WHO Functional Class III to improve exercise capacity and symptoms, and in WHO Functional Class II where some improvements have 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.

The approval makes Tracleer the only PAH therapy with an approved pediatric formulation for treating children from two years of age, said the company.

Martine Clozel, Pediatrician and Chief Scientific Officer, Actelion, said: “Our team is very proud of this achievement. We decided very early in the development of Tracleer to devote time and effort to the development of a formulation adapted to the daily treatment of children suffering from PAH, even if it was representing a small population. It has been a long, but ultimately extremely rewarding journey, which had begun even before the first marketing authorization of Tracleer.”

Isaac Kobrin, MD and Head of Clinical Development at Actelion, added: “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.”