ENCYSIVE'S THELIN RECEIVES EUROPEAN AUTHORIZATION
Encysive Pharmaceuticals announced it has received the formal decision letter from the European Commission granting marketing authorization for Thelin (sitaxentan sodium) 100-mg tablets. The drug is indicated for the treatment of patients with pulmonary arterial hypertension (PAH) to improve exercise capacity. Efficacy has been shown in primary PAH and pulmonary hypertension associated with connective tissue disease. Thelin is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment for PAH.
The approval is based on the largest database of patients with PAH ever assembled in a marketing authorization application, with more than 1,000 PAH patients receiving Thelin in clinical trials.