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今日,23/11/2021, fda會審核武田一隻新藥申請

$武田制药(TAK)$

Maribavir(TAK-620)是一款UL97蛋白激酶抑制剂,它具有抑制CMV病毒复制的创新机制。据报道,它目前是唯一能靶向抑制UL97蛋白激酶的CMV抗病毒药物,与已有疗法相比具有更高的安全性。美国FDA曾授予了maribavir突破性疗法认定,用于治疗对既往疗法耐药或难治的移植患者的CMV感染和疾病。

本次新药申请是基于maribavir的关键性3期临床试验结果,试验达到了主要终点,即在R/R CMV感染的移植患者中,它与常规抗病毒治疗相比表现出优效性。

武田官方稱已通過所有終點:

Takeda's Maribavir Phase 3 Clinical Trial Met Primary Endpoint of Superiority to Conventional Antiviral Therapy in Transplant Recipients With Refractory, With or Without Resistance, Cytomegalovirus Infection/Disease

“We are excited by the results of the SOLSTICE trial, which were shared in greater detail with the scientific community at the 2021 TCT Meetings. This is an important development for transplant patients who are at increased risk of CMV, which if not controlled, can pose grave challenges. Maribavir, if approved, has the potential to redefine treatment for post-transplant refractory, with or without resistance, CMV,” said Obi Umeh, MD, Vice President and Maribavir Global Program Leader, Takeda.

如果批准,

maribavir将成为首个治疗接受器官移植或造血细胞移植后,发生难治性、有或无耐药性(R/R)巨细胞病毒(CMV)感染患者的药物。

未知是否會批,所以今日股票會有波動。

另外,arkk wood 契媽這一陣子在減持tak。