Switzerland’s Actelion says that European regulators have approved its lead product Tracleer for the treatment of patients with mildly symptomatic pulmonary arterial hypertension.

Tracleer (bosentan) has been approved and available in the European Union since 2002 for pulmonary arterial hypertension and Actelion says it is the first PAH treatment ever to be investigated in a clinical study that exclusively enrolled patients with mildly symptomatic PAH. The approval extension was based on a 185-patient study.

Chief executive Jean-Paul Clozel, noted that the study, called EARLY, showed that “even patients with mild symptoms are at risk of rapid deterioration”. He added that Tracleer, a dual endothelin receptor antagonist, is the only PAH medicine to have demonstrated a delay in disease progression in three independent placebo-controlled, randomised clinical studies”. Regulatory proceedings to extend the label for bosentan are ongoing in the USA and elsewhere, Actelion added.

The European Union decision to expand the label on Tracleer can only help boost sales. First-half revenues of the drug were up 17% to 605 million Swiss francs, out of total group turnover of 676.0 million francs.

However Actelion is trying to cut its dependence on Tracleer and would appear to be making progress in that regard, having recently signed a licensing deal with GlaxoSmithKline on its investigational insomnia compound almorexant which could be worth up to 3.3 billion Swiss francs.