赛诺菲一款BTK抑制剂在国内申报上市
MPA
发表于 5 일전
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公开资料显示,rilzabrutinib是一款口服、可逆的共价BTK抑制剂,可以选择性地抑制BTK靶点,同时有可能降低产生脱靶副作用的风险。今年11月,赛诺菲在美国血液学会(ASH)年会上公布了该产品针对免疫性血小板减少症(ITP)适应症的3期临床研究积极结果。赛诺菲此前表示,rilzabrutinib有希望成为首个治疗ITP适应症的BTK抑制剂。该产品目前正在美国和欧盟接受监管审查。
该疗法还曾获得美国FDA授予快速通道资格与孤儿药资格,用于治疗ITP。除了ITP适应症,该产品还正在针对慢性自发性荨麻疹、哮喘、IgG4相关性疾病、温抗体型自身免疫性溶血性贫血等进行2期临床研究。
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