In the United States, Tracleer® is approved for the treatment of pulmonary arterial hypertension functional class II - IV to improve exercise capacity and decrease the rate of clinical worsening. Patients with class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these benefits are sufficient to offset the risk of liver injury in class II patients, which may preclude future use as their disease progresses.
In Europe it is approved for treatment of PAH functional class III to improve exercise capacity and symptoms, as well as PAH functional class II, where some improvements have also been shown. In the EU Tracleer® is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Regulatory review and approval for the inclusion of functional class II in the Tracleer® label is ongoing on a worldwide basis.
Additionally, a quadrisect, dispersible 32mg tablet formulation of Tracleer® has been approved in the EU for the treatment of PAH in children aged from 2 years.
