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Encysive Thelin PAH submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Encysive submits its oral endothelin receptor antagonist Thelin (sitaxsentan) for treatment of pulmonary arterial hypertension, the firm announces May 25. The NDA "contains the largest database ever assembled in a regulatory filing for PAH, with approximately 900 PAH patients receiving Thelin," the Houston-based company said. The NDA includes two pivotal trials, the second of which (STRIDE-2) was conducted under a special protocol assessment with FDA (1Pharmaceutical Approvals Monthly September 2004, In Brief). Thelin would be entering an increasingly competitive market: CoTherix' inhaled prostacyclin Ventavis (iloprost) cleared FDA last December (2Pharmaceutical Approvals Monthly January 2005, p. 3) and Pfizer's Revatio (sildenafil) cleared FDA June 3 (see related brief, p. 15)...

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