Actelion files for EU approval of hypertension therapy Uptravi

Actelion has filed for European regulatory approval of Uptravi, the first selective oral IP prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension.

A centralised marketing authorisation application has been sunbmitted to the European Medicines Agency for the selexipag-based therapy, which has demonstrated its safety and efficacy in a pivotal phase III trial called Griphon.

In this 1,156-patient study, it was shown that the new drug decreased the risk of morbidity/mortality events versus placebo by 39 percent. Patients were treated for up to 4.2 years.

Submissions to the US Food and Drug Administration and other territories are also forthcoming.

Dr Jean-Paul Clozel, chief executive officer of Actelion, said: "I am delighted that we have been able to submit this application in 2014, demonstrating once again the power of our commitment to bring forward new solutions for the pulmonary arterial hypertension community."

Uptravi, along with the company's other new pulmonary arterial hypertension therapy Opsumit, are expected to be key drivers of growth for Actelion in the coming years.