Australian approval for Encysive's Thelin

12 March 2007

The Australian Therapeutic Goods Administration (TGA) has granted marketing approval for US firm Encysive Pharmaceuticals Thelin (sitaxentan sodium) 100mg tablets as a once-daily oral treatment for patients with pulmonary arterial hypertension.

The drug is indicated for the treatment of PAH in patients with New York Heart Association/World Health Organization functional class III symptoms to improve exercise ability. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease. Thelin is the first selective endothelin A receptor antagonist and first once daily oral treatment available for patients with PAH.

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