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基石藥業-B(02616.HK):阿伐替尼片具良好安全性
基石藥業-B(02616.HK)公布,其合作夥伴Blueprint Medicines(BPMC.US)近日在2023年美國過敏、哮喘和免疫學會(AAAAI)年會上公布泰吉華(阿伐替尼片)用於治療惰性系統性肥大細胞增多症(ISM)患者中的PIONEER研究的詳細數據。 其中,關鍵亮點包括泰吉華在總症狀評分方面取得統計學顯著性與有臨床意義的改善,並隨著時間的推移而加深,所有類型的症狀均有改善。泰吉華在肥大細胞增多症生活品質問卷(MC QoL)顯示出具有統計學顯著性與臨床意義的改善。與安慰劑相比,泰吉華具有良好的安全性,支持ISM長期治療的臨床需求。 基於該研究數據,Blueprint Medicines已向美國食品藥監局(FDA)提交泰吉華的補充新藥申請(sNDA),並向歐洲藥品管理局(EMA)提交泰吉華的二類變更行銷授權申請(MAA),用於治療ISM患者。FDA已授予泰吉華該項申請的優先審查資格,處方藥使用者付費法案(PDUFA)規定的行動日期為今年5月22日,同時,EMA已經確認泰吉華的MAA。
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