Actelion wins positive opinion for pediatric formulation of hypertension drug

Swiss biopharmaceutical company Actelion has reported that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has issued a positive opinion for the pediatric formulation of bosentan for the treatment of pulmonary arterial hypertension.

According to the company, the Committee for Medicinal Products for Human Use recommended that the European Commission approve the new dispersible 32mg tablet formulation of bosentan, which was specifically developed for children, and which was studied in children with pulmonary arterial hypertension (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 two years of age.

According to Actelion, Bosentan is an oral, dual endothelin receptor antagonist, which is already approved as Tracleer in Europe for the treatment of PAH. Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.

The new, quadrisect, dispersible 32mg tablet formulation, specifically developed for children above the age of two years, allows for simple dose calculation and administration, the company said.