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              2014年7月FDA批準新藥tavaborole
              2014-07-17 08:21:04 來源:有機化學網 瀏覽:6821

              2014年7月7日,FDA批準了Anacor旗下Kerydin(5% Tavaborole溶液)用于局部治療趾甲真菌感染。
              Tavaborole是首個用于治療趾甲感染的氧硼戊環(oxaborole)類抗真菌藥物,Anacor專注于基于硼元素的藥物的研發和生產,根據其最新的消息,Tavaborole未來也可用于手指甲感染。
              該藥物是FDA在一個月內批準的第二個局部治療趾甲真菌感染的藥物,其在6月6日批準了Valeant 旗下Jublia(10% Efinaconazole溶液)的上市申請。
              Tavaborole的適應證為紅色毛癬菌或須毛癬菌引起的趾甲真菌感染。說明書推薦每日一次用于感染的趾甲,療程共48周,根據Anacor的建議,不需要進行趾甲清創術。
              FDA是基于2項共納入1194例患者的多中心、隨機、雙盲臨床試驗確定Tavaborole的有效性和安全性的。
              臨床試驗將Tavaborole與含有活性護膚品成分的局部賦形劑相對比。主要終點為“完全治愈“,定義為趾甲完全干凈(0%的臨床病變),同時KOH測試及培養陰性確定真菌感染治愈。
              在兩個試驗中,完全治愈的比例分別6.5%和9.1%,各自使用賦形劑的對照組完全治愈的比例為0.5和1.5%。
              次要終點為“完全或接近完全治愈”,即真菌感染治愈的同時臨床病變小于10%,或者僅有真菌感染的治愈。在這兩方面Tavaborole均表現出明顯優勢

              中文名稱: AN-2690;TAVABOROLE;AN2690
              中文同義詞: AN-2690;TAVABOROLE;AN2690
              英文名稱: 5-FLUOROBENZO[C][1,2]OXABOROL-1(3H)-OL
              英文同義詞: 5-FLUOROBENZO[C][1,2]OXABOROL-1(3H)-OL;AN 2690;Tavaborole
              CAS號: 174671-46-6
              分子式: C7H6BFO2
              分子量: 0
              EINECS號:
              Mol文件: 174671-46-6.mol

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