Encysive’s Thelin Gets EU Nod Ahead Of U.S.
This article was originally published in The Pink Sheet Daily
Executive Summary
EU marketing authorization of the pulmonary arterial hypertension treatment follows Encysive’s receipt of a second “approvable” letter for sitaxentan sodium from FDA.
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The European Commission has granted marketing authorization to Encysive's pulmonary arterial hypertension drug Thelin (sitaxentan), the company announced Aug. 11. The Houston firm said it is awaiting a formal decision letter from the commission prior to releasing additional information. The endothelin receptor antagonist received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in June (1 (Also see "Thelin Gets EMEA Committee Approval Recommendation" - Pink Sheet, 3 Jun, 2006.)). The CHMP recommended the drug for the indication of "treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity." In the U.S., Encysive has experienced a harder road to approval. The company received its second "approvable" letter for Thelin from FDA July 24 after responding to FDA's initial March approvable letter in May (2 (Also see "Encysive Holds Hope For Thelin Despite Receiving Second “Approvable” Letter" - Pink Sheet, 25 Jul, 2006.)). Following the approvable letter, CEO Bruce Given said that he believed FDA had left the door open for further discussion and that the firm expected to meet with the agency in August. The letter suggested additional clinical trial work, but Given said Encysive hoped to avoid conducting additional trials. -Jessica Merrill |