Actelion's PAH drug Opsumit approved in EU

Switzerland-based Actelion (SIX: ATLN) has received European Commission approval for Opsumit (macitentan), a novel dual endothelin receptor antagonist (ERA), for the long-term treatment of pulmonary arterial hypertension (PAH) in the European Union.

Opsumit was approved by the US Food and Drug Administration on 18 October 18, and was launched in the USA last month (The Pharma Letter November 5), and by Health Canada in November 2013. It is also undergoing regulatory assessment in other countries including Switzerland. In the EU, the first launch of the drug is planned for February 2014 in Germany.

The EU approval is clearly more good news for Actelion, Europe’s largest biotech firm, which is seeking to replace its leading marketed drug, the PAH treatment Tracleer (bosentan), sales of which are falling due to the competitive situation in the USA, as well as price cuts in other regions.