Actelion’s Opsumit approved as PAH therapy in Europe

Actelion has announced that its drug Opsumit has been approved by the European Commission as a treatment for pulmonary arterial hypertension (PAH).

The regulatory body has endorsed the product as a monotherapy or in combination for the long-term treatment of PAH in adult patients who have been designated in WHO Functional Class II to III.

Clinical trials have demonstrated the efficacy of the drug in PAH populations including idiopathic and heritable PAH, PAH associated with connective tissue disorders and PAH associated with corrected simple congenital heart disease.

Opsumit was approved in the US in October 2013 and in Canada last month. Actelion is seeking further approvals for the drug in various other countries, including Switzerland.

Dr Jean-Paul Clozel, chief executive officer of Actelion, said: "We believe that Opsumit represents a major step forward for the management of PAH. Our company strategy of sustaining and growing our PAH franchise has yet again been bolstered by this approval."

The success of Actelion's PAH unit was highlighted as a key driver of growth in the third quarter of 2013, with further expansion anticipated in the near future.