Bosentan (Tracleer) receives positive CHMP opinion for pediatric formulation
Actelion Ltd announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for the pediatric formulation of bosentan (Tracleer®) for the treatment of pulmonary arterial hypertension (PAH).
The CHMP recommended that the European Commission approves the new dispersible 32mg tablet formulation of bosentan, which was specifically developed for children, and which was studied in children with PAH down to the age of two years in the pediatric program. The European Commission is expected to make a final decision within two months. Actelion continues to work with authorities world-wide, including the US, to authorize the new dispersible formulation and to expand the PAH product information for bosentan bringing the treatment age down to 2 years of age.
Bosentan is an oral, dual endothelin receptor antagonist, which is already approved as Tracleer® in Europe for the treatment of PAH; in WHO functional class III PAH to improve exercise capacity and symptoms and in PAH 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.
The pediatric program investigated the pharmacokinetics, tolerability and safety of the new dispersible formulation of bosentan. The safety profile was consistent with that seen in the adult population.
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