Actelion drug Tracleer receives positive CHMP opinion

Actelion has announced that Tracleer (bosentan) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency regarding an extension of the indication of the compound.

The committee has recommended the approval of the drug for the reduction of the number of new digital ulcers in systemic sclerosis and ongoing digital ulcer disease patients.

Currently indicated for the treatment of pulmonary arterial hypertension to improve exercise ability and lower the rate of clinical worsening, Tracleer is an orally-administered dual endothelin receptor agonist.

The compound blocks the damaging effects of increased endothelin levels in scleroderma patients with pulmonary arterial hypertension.

Jean-Paul Clozel, chief executive officer of the company, said: “Actelion has been committed to fully exploring the benefits of dual endoethlin receptor antagonism.

“This indication in digital ulceration is the first application outside of pulmonary arterial hypertension.”

He added that the firm would soon ask for a review by the regulatory authorities of the data relating to the compound as a treatment for chronic thromboembolic pulmonary hypertension.

Earlier this month, Actelion announced that Tracleer had met its primary endpoint of lowering pulmonary vascular resistance in a placebo-controlled clinical investigation of the compound in patients with inoperable forms of this disease.