Facts & Figures

Tracleer® (bosentan) is an oral dual endothelin receptor antagonist, which is currently licensed for the treatment of pulmonary arterial hypertension (WHO Group I), a chronic, life-threatening disorder which severely compromises the function of the lungs and heart. 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.

Zavesca® (miglustat) is the first and only oral medication approved for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease, and it may only be used in those patients for whom enzyme replacement therapy is unsuitable.

Zavesca® is also approved in the European Union for the treatment of progressive neurological manifestations in adult patients and pediatric patients with Niemann-Pick type C disease (NP-C). Zavesca® is the first treatment to be approved for patients with Niemann-Pick type C disease, a very rare, invariably progressive and eventually fatal neurodegenerative genetic disorder affecting both children and adults.

Ventavis® (iloprost) is an inhaled formulation of iloprost, approved for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms.