Actelion expects bosentan decision in coming months

Actelion expects the European Commission to make a final decision on its drug application for the medication bosentan (Tracleer) over the next two months.

The 32 mg tablet has received a positive opinion from the Committee for Medicinal Products for Human Use to aid pulmonary arterial hypertension (PAH) in youngsters.

At present, there is no medication for children aged below 12 with the condition and, if approved, bosentan will be the only PAH treatment with a paediatric formulation.

Investigations of the drug for use in youngsters found it was tolerable and safe, the firm added.

Bosentan has already been approved as the medication Tracleer in Europe to treat certain patients with PAH and also some with systematic sclerosis to reduce the number of ulcers.

Last week, Actelion released its financial figures for the first three months of the year.

Managing director and chief executive of the company Jean-Paul Clozel said the firm had performed strongly, adding he looked forward to the completion of a number of phase III clinical trials.

Positive results from investigations could lead to the business growing rapidly, Mr Clozel concluded.