Encysive is seeking to market Thelin (sitaxsentan) as a 100 mg once daily oral treatment for patients with pulmonary arterial hypertension (PAH). The company filed an application to market Thelin in the US earlier this month.
If accepted by the European Agency, Encysive would be able to market the drug in all 25 member states of the European Union under the central licensing procedure.
Encysive’s regulatory filings contain the largest database ever assembled for PAH, with approximately 900 PAH patients receiving Thelin in clinical evaluations. The company conducted two randomized, placebo-controlled pivotal phase III studies in support of worldwide product registrations.
Thelin is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important.