Post-marketing surveillance studies reported on 4 September at the European Society of Cardiology meeting in Stockholm demonstrated the long-term safety of Actelion’s Tracleer (bosentan) in patients with pulmonary arterial hypertension (PAH). This conclusion is based on data from TRAX PMS, which was set up at the request of the EMEA following abnormal, but reversible, increases in liver enzymes in patients receiving Tracleer in pivotal clinical trials.
These results will boost the fortunes of Actelion, the Swiss-based biopharmaceutical company. Tracleer is the company’s first drug and has been approved for the treatment of PAH in the USA, the European Union, Canada, Australia and Switzerland.
TRAX PMS will also reassure doctors treating patients with PAH, a serious, progressive condition, caused by blockage of the arteries in the lung. The results are severe breathlessness, physical disability and ultimately right-sided heart failure. Previously considered a very rare condition, PAH is increased recognised in association with other diseases such as systemic sclerosis and congenital heart disease.