Thelin Gets EMEA Committee Approval Recommendation
This article was originally published in The Pink Sheet Daily
Executive Summary
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization approval of Encysive's pulmonary arterial hypertension therapy Thelin (sitaxsentan), the agency announced June 2
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The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization approval of Encysive's pulmonary arterial hypertension therapy Thelin (sitaxsentan), the agency announced June 2. The CHMP recommendation will be referred to the European Commission, which will hand down a final decision within 90 days. Encysive submitted the marketing authorization application for Thelin in July 2005. Thelin is currently pending at FDA. The firm submitted a complete response to a March 24 "approvable" letter in May (1 (Also see "Encysive Avoids Additional Trials For Thelin NDA" - Pink Sheet, 25 May, 2006.)). Thelin has orphan drug designation in both the EU and the U.S. CHMP also adopted positive opinions of Takeda's type II diabetes therapy Competact (pioglitazone/metformin), Procter & Gamble's testosterones Intrinsa and Licensa for female sexual dysfunction, and TopoTarget's orphan drug Savene (desrazoxane) for treating leakage of intravenously administered chemotherapy into surrounding tissue. Takeda's pioglitazone/metformin combination Actoplus Met was approved in the U.S. in August (2 (Also see "Takeda’s Actoplus Met For Type 2 Diabetes Will Launch In October" - Pink Sheet, 30 Aug, 2005.)). TopoTarget's desrazoxane Totect was granted priority review by FDA April 12. -Kathleen Michael |