百濟神州(06160.HK):加拿大藥監部門批准百悦澤®用於治療華氏巨球蛋白血癥患者
格隆匯 3 月 3日丨百濟神州(06160.HK)2021年3月2日(美國東部時間)宣佈,加拿大藥監部門已批准百悦澤®(澤布替尼)用於治療華氏巨球蛋白血癥(WM)患者的新藥上市申請。
百濟神州北美兼歐洲首席商務官Josh Neiman先生表示:“百悦澤®是一款具有高度選擇性的BTK抑制劑,設計旨在為血液學惡性腫瘤患者帶來深度且持久的緩解,並同時降低某些副作用的出現頻率。我們期待這項獲批能夠將百悦澤®這款潛在同類最優的BTK抑制劑帶給加拿大的WM病患。我們將不斷努力,以確保百悦澤®在加拿大的可及性,並向全球更多市場的患者提供這一創新藥物。”
加拿大多倫多大學副教授兼瑪格麗特公主癌症中心臨牀研究員Christine Chen醫學博士表示:“WM是一種罕見卻十分嚴重的疾病。儘管BTK抑制劑已經改善了WM 的整體治療,但並非所有患者都能對此產生緩解,而且副作用導致的不耐受仍然是一個問題,尤其對於年長患者而言。ASPEN的臨牀試驗結果證明了百悦澤®有望能為WM患者帶來臨牀益處及安全性方面的優勢,為這一患者羣體帶來了新的希望。”
加拿大華氏巨球蛋白血癥基金會(WMFC)主席Paul Kitchen先生評論道:“WMFC 為加拿大藥監部門批准百悦澤® (澤布替尼)作為一項用於治療WM的療法感到興奮,這將進一步為加拿大WM患者羣體帶來多款高品質療法選項。正如ASPEN臨牀試驗的結果一樣,百悦澤®有望能夠為加拿大患者改善治療效果。”
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