Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced the commercial availability of Thelin(r)(1) (sitaxentan sodium(2)) 100 mg tablets in Sweden.
THELIN is approved for the treatment of pulmonary arterial hypertension (PAH) and has received reimbursement approval for use in Sweden. Encysive received European Union (EU) marketing authorization for THELIN from the European Commission in August 2006. THELIN 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 (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).
"A number of evidence-based treatment options for PAH have been developed in recent years. Sitaxentan provides us with another therapy to tailor and optimize treatment for the individual patient," stated Bjorn Ekmehag, MD, Director of the Pulmonary Hypertension Centre, Lund Sweden.
The EU's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the EU. THELIN has been launched in the United Kingdom, Germany, Ireland, Spain, France, Italy, Belgium, Luxembourg and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained.
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