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和黃醫藥(00013.HK)收到FDA回覆 新藥上市申請不獲批
阿思達克 05-03 00:57
和黃醫藥(00013.HK)公布,FDA(美國食品藥品監督管理局)已就索凡替尼用於治療胰腺和非胰腺神經內分泌瘤的新藥上市申請發出完整回覆函。FDA認為,當前基於兩項成功的中國III期研究以及一項美國橋接研究的數據包尚不足以支持藥品現時於美國獲批。回覆函中表明,需要納入更多代表美國患者人群的國際多中心臨床試驗(MRCT)來支持美國獲批。和黃醫藥正在與FDA合作,以評估下一步行動。 和黃醫藥首席執行官兼首席科學官蘇慰國博士表示,儘管此次 FDA 的決定令人感到失望,但依然對索凡替尼治療神經內分泌瘤患者的臨床價值充滿信心,期待與 FDA 繼續保持溝通,以制定計劃將索凡替尼帶向為美國的患者。 2020年5月,和黃醫藥在新藥上市申請前會議上與FDA達成一致,索凡替尼用於治療胰腺和非胰腺神經內分泌瘤患者的兩項取得積極結果的中國III期研究,連同索凡替尼美國橋接研究的現有數據,可構成支持在美國提交新藥上市申請的依據。FDA於2021年6月30日受理了索凡替尼提交的新藥上市申請。
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