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葛蘭素史克(GSK)的Efimosfermin獲得FDA和EMA關於治療大型動物衛生事件(MASH)的認定。

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-- 葛蘭素史克(GSK)週一宣布,其肝臟治療藥物efimosfermin獲得美國食品藥物管理局(FDA)授予的突破性療法認定和歐洲藥品管理局(EMA)授予的優先藥物認定,用於治療代謝功能障礙相關性脂肪性肝炎(MASH)。 FDA的認定旨在加快藥物的研發和審批,而EMA的認定則提供科學和監管支持。 這些認定是基於中度至重度肝硬化患者的II期臨床試驗數據,數據顯示,與安慰劑相比,efimosfermin可改善肝纖維化並緩解MASH症狀。該公司表示,該療法總體上具有良好的耐受性和安全性。 該公司表示,針對伴隨肝硬化的MASH患者的III期臨床試驗預計今年啟動。

Price: $54.48, Change: $+0.04, Percent Change: +0.06%

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