Actelion’s bid to expand its Tracleer franchise has been given a lift after regulators in Europe approved use of the Swiss firm’s pulmonary arterial hypertension drug in children.
The company noted that the European approval makes Tracleer (bosentan) the only PAH therapy with an approved paediatric 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.
Martine Clozel, chief scientific officer at Actelion, said “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”. The dispersible 32mg tablet formulation of bosentan allows “a convenient, accurate and more flexible dosing regimen according to low body weight”, Actelion says, and the safety and tolerability profile of the drug in children was consistent with that observed in trials in the adult population.
The company also quoted Maurice Beghetti, head of the Pediatric Cardiology Unit at Hopital des Enfants, Geneva, as saying that “it is great to see Actelion leading the way in providing a treatment fully tailored for children, from the precise dosing to the flavour”.
Tracleer had sales of 1.29 billion francs in 2008, up 10% on 2007, and Actelion is also studying the drug as a treatment for idiopathic pulmonary fibrosis.
