Actelion receives recommendation to extend use of Tracleer

Actelion has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended that European Commission allow the use of Tracleer (bosentan) to be extended in Pulmonary Arterial Hypertension (PAH).

The CHMP’s recommendation is that the drug is used for patients with PAH functional class (FC) II.

The European Commission is expected to reach a decision within the next two to three months.

There are four World Health Organisation (WHO) FCs for PAH with class I being the least severe and class IV the most severe.

Tracleer (bosentan) is currently licensed for use in Europe for PAH FC III to improve exercise capacity and symptoms, while it is licensed in the US for PAH FC III and IV to improve exercise capacity and decrease the rate of clinical worsening.

Studies carried out exclusively on FC II patients, highlighted the rapid progression of PAH, regardless of symptoms and showed the benefit of treating with Tracleer (bosentan), according to Actelion.

Earlier this month, Actelion made a presentation at the Goldman Sachs 29th Annual Global Healthcare Conference in California.