Actelion seeks authorisation for further use of Tracleer

Actelion will continue to work to try and expand the use of the treatment Tracleer in patients with less severe forms of pulmonary arterial hypertension (PAH), it has stated.

The company filed a supplemental new drug application in August 2007 and it has now received a complete response letter.

Its has been informed that the risk evaluation and mitigation strategy (REMS) the firm submitted needs to be finalised and approved before a conclusion can be reached.

Since November 2001, Tracleer has been commercially available for sufferers of PAH who have Who III-IV symptoms.

Now the Food and Drug Administration will analyse it for use in those people who have forms of the disease which are not as intense.

Managing director and chief executive officer of Actelion commented: “We will continue to diligently work ? on the ongoing REMS submission in order to expand the US product label to include less severe PAH patients.”

Last month, Actelion announced it had entered into a definitive agreement to acquire a thermostable formulation of epoprostenol sodium for the intravenous treatment of PAH from GeneraMedix.