ENCYSIVE'S THELIN APPROVED BY EUROPEAN COMMISSION

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.