百濟神州(06160.HK):FDA受理百悦澤®針對華氏巨球蛋白血癥的新適應症上市申請
格隆匯 2 月 18日丨百濟神州(06160.HK)於2021年2月17日(美國東部時間)宣佈,美國食品藥品監督管理局(FDA)已受理百悦澤®(澤布替尼)用於治療華氏巨球蛋白血癥(WM)患者的新適應症上市申請(sNDA),處方藥申報者付費法案(PDUFA)日期為2021年10月18日。
百濟神州血液學首席醫學官黃蔚娟醫學博士表示:“WM是一種罕見且十分嚴重的疾病,我們非常欣慰FDA已受理百悦澤®用於治療這項疾病的新適應症上市申請。近年來,BTK抑制劑雖然已經改善了WM的整體治療,但是罹患不同亞型的患者對其產生的緩解還存在差異,同時毒性仍然是個問題。我們會在接下來的幾個月中不斷與FDA進行溝通,期待百悦澤®能成為美國WM患者的一項全新治療方案。”
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