Encysive Pharmaceuticals has announced the commercial availability of Thelin 100 mg tablets in the republic of Ireland for the treatment of pulmonary arterial hypertension (PAH).
The company 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 will be available through the High Tech Scheme in Ireland.
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 and pulmonary hypertension associated with connective tissue disease (CTD).
"Clinical results demonstrate that Thelin can safely and effectively help later-stage primary and CTD-associated PAH patients manage their symptoms," said Sean Gaine, consultant respiratory physician, pulmonary hypertension unit, mater Misericordiae University Hospital, Dublin, Ireland. "Thelin also possesses two attractive characteristics, it is orally administered and requires only once-a-day dosing, which provides patients with a simpler treatment regimen."
"PAH can progress into an extremely debilitating condition, especially for patients in whom it is secondary to the connective tissue disease scleroderma," commented Ann Kennedy, CEO of the Irish Raynaud's and Scleroderma Society. "We are working with physicians on earlier recognition of PAH symptoms and can not overstress the importance of evaluating CTD patients for this condition. Promising new treatment options are now available, but patients must be properly screened and diagnosed before they can take advantage of these therapies."
The European Commission's centralized licensing procedure permits Encysive to market Thelin in all 27 member states of the (EU). Thelin will be launched in successive EU member states as local government approval for reimbursement is obtained.