智通财经APP获悉,5月8日,CDE官网显示,赛诺菲的“注射用卡普赛珠单抗”报上市,适应症为与血浆置换和免疫抑制疗法联合治疗获得性血栓性血小板减少性紫癜(aTTP)(也称为免疫介导的血栓性血小板减少性紫癜),适用群体范围为成人和12岁及以上体重至少40kg的青少年患者。此前该适应症曾被纳入优先审评。
aTTP是一种罕见的、危及生命的自身免疫性血液疾病。在aTTP中,大量血管性血友病因子(vWF)的积累会导致全身小血管中大量血栓形成,从而导致严重的血小板减少症(血小板计数极低)、微血管病性溶血性贫血(红细胞因破坏而丢失)和缺血(身体部分血液供应受限)。
卡普赛珠单抗(Caplacizumab)是一种针对vWF的纳米抗体,旨在抑制vWF和血小板之间的相互作用。该药最初由Ablynx开发,赛诺菲于2018年收购了Ablynx公司,从而将其收入麾下。
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