The USA's Encysive Pharmaceuticals has launched Thelin (sitaxentan sodium) 100mg tablets in France for the treatment of pulmonary arterial hypertension. The firm received European Union marketing authorization for the agent from the European Commission in August 2006 and it is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment available for patients with PAH.
Thelin is indicated for improving exercise capacity in PAH patients classified as World Health Organization functional class III. According to the firm, the drug's efficacy has been shown in both primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
The European Commission's centralized licensing procedure permits Encysive to market Thelin in all 27 member states of the EU. The agent has already been launched in the UK, Germany, Ireland, Spain and the Netherlands and will be introduced in additional EU member states as local governmental reimbursement approval is obtained.
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