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Home » ENCYSIVE'S THELIN APPROVED BY EUROPEAN COMMISSION
ENCYSIVE'S THELIN APPROVED BY EUROPEAN COMMISSION
August 21, 2006
Encysive announced Aug. 11 that the European Commission has authorized it to market its hypertension drug Thelin in 100-mg tablets. The approval allows Encysive to market the drug in all 25 member states of the European Union (EU).
Thelin (sitaxentan sodium) is the first once-daily oral treatment available for patients with pulmonary arterial hypertension (PAH), a condition that affects approximately 100,000 to 200,000 people in North America and Europe, the drugmaker said. It is also the first selective endothelin A receptor antagonist, preventing blood vessel constriction by blocking the action of the protein endothelin.
The approval is the result of a trial of more than 1,000 patients receiving Thelin, the largest group of PAH patients ever assembled for a European marketing approval application.
Encysive intends to market Thelin immediately in the UK and Germany, with launches in other EU member countries to follow.
KEYWORDS FDAnews Drug Daily Bulletin
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