-- 根據週五提交給澳洲證券交易所的文件顯示,Clinuvel Pharmaceuticals(ASX:CUV)表示,歐洲藥品管理局(EMA)已提議基於「整體證據」監管方法評估該公司用於治療系統性白斑的藥物Scenesse。 白斑症是一種慢性皮膚病,會導致皮膚出現白色斑塊。 Clinuvel表示,在EMA就Scenesse計畫進行的3期臨床試驗設計提出最終建議後,該試驗的主要終點將是除手腳以外,全身50%或以上皮膚色素恢復的患者比例。 該試驗計劃於今年下半年啟動,將使用基線變化的照片證據來評估主要和次要終點。 Clinuvel也表示,EMA建議膚色較深的患者先接受系統性治療,因為這類患者的病情更為明顯。
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