Pfizer has informed The European Medicines Agency about its voluntary decision to withdraw Thelin from the market worldwide because of the new information on two cases of fatal liver injury. Pfizer has also decided to discontinue all ongoing clinical trials.
Thelin, which contains the active substance sitaxentan, has been authorised in the European Union (EU) since 2006 for the treatment of pulmonary arterial hypertension.
Thelin has been known to be associated with liver toxicity and since its initial marketing authorisation has been contra-indicated in patients with mild to severe hepatic impairment (Child-Pugh Class A-C) and elevated aminotransferases prior to initiation of treatment.
At this stage, patients taking Thelin or participating in Thelin studies are advised not to stop treatment and to consult their treating physician to review their treatment at their next scheduled appointment.
The Agency’s scientific Committee for Medicinal Products for Human Use (CHMP) will look at this issue during their plenary meeting on 13–16 December 2010 and will provide detailed advice for patients and prescribers.
What is Thelin?
Thelin is used to treat adults (aged 18 years or over) with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity). PAH is abnormally high blood pressure in the arteries of the lungs. Thelin is used in patients with class III disease. The ‘class’ reflects the seriousness of the disease: ‘class III’ involves marked limitation of physical activity. Thelin has been shown to be effective in PAH with no identified cause and PAH caused by connective tissue disease.
As the number of patients with pulmonary arterial hypertension is low, the disease is considered ‘rare’, and Thelin was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 October 2004.
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