Actelion receives EU approval for hypertension therapy Uptravi

Actelion has announced that its new pulmonary arterial hypertension (PAH) therapy has been approved by the European Commission.

The orally active, selective IP prostacyclin receptor agonist has been approved for the long-term treatment of PAH, either as a combination therapy in adult patients insufficiently controlled with an endothelin receptor antagonist or a phosphodiesterase type 5 inhibitor, or as a monotherapy in patients who are not candidates for these therapies.

Data from clinical studies has shown the efficacy of these therapies in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

Specifically, the EU approval was based on positive findings from the phase III GRIPHON trial, a placebo-controlled study that represented the largest ever for this disease.

Dr Jean-Paul Clozel, chief executive officer of Actelion, said: "We are very pleased with today's approval of Uptravi by the European Commission, as it enables us to offer this outstanding oral medication, which provides long-term outcome benefits even for patients receiving background therapy, to PAH patients in Europe."

Following this regulatory approval, the company will seek to roll the drug out across Europe as soon as possible, beginning with a German launch.