Actelion submits hypertension therapy for EU approval

Actelion has announced that it has submitted a registration dossier to the European Medicines Agency for assessment of its new drug Opsumit.

The company is seeking regulatory approval for the macitentan-based therapy as a treatment for pulmonary arterial hypertension, having also submitted the compound for US approval last month.

Results from the pivotal phase III trial Seraphin showed that Opsumit was able to deliver a reduction in the risk of morbidity and mortality events compared to placebo, while safety data demonstrated that the drug was well-tolerated.

Secondary data from the same trial illustrated the drug's efficacy in minimising the risk of all-cause mortality and hospitalisation.

The company will continue to prepare submissions for regulators in countries around the world, including Switzerland.

Dr Jean-Paul Clozel chief executive officer of Actelion, said: "We have worked hard to prepare the dossiers for a timely submission to both health authorities and I am very happy that regulatory processes in both the US and the EU could be initiated."