FDA批准长效版依库丽单抗-Ravulizumab

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-02-24 23:10
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(Summary description)2018年12月21日，FDA批准AlexionPharmaceuticals公司开发的新药ULTOMIRIS（Ravulizumab）上市，用于治疗阵发性睡眠性血红蛋白尿（PNH），该药是第一款长效C5补体抑制剂。FDA原定在2019年2月18日之前对ULTOMIRIS的申请做出决定，这一批准比预计时间提前了两个月。过去，罕见病药物依库珠单抗（商品名Soliris）用于治疗阵发性夜间血红蛋白尿症

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FDA批准长效版依库丽单抗-Ravulizumab

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-02-24 23:10
Views:

Information

2018年12月21日，FDA批准Alexion Pharmaceuticals公司开发的新药ULTOMIRIS（Ravulizumab）上市，用于治疗阵发性睡眠性血红蛋白尿（PNH），该药是第一款长效C5补体抑制剂。FDA原定在2019年2月18日之前对ULTOMIRIS的申请做出决定，这一批准比预计时间提前了两个月。

过去，罕见病药物依库珠单抗（商品名Soliris）用于治疗阵发性夜间血红蛋白尿症（PNH）、非典型溶血性尿毒症综合征（aHUS）和抗AchR抗体阳性重症肌无力（gMG）。依库珠单抗2007年首次在美国上市，2018年09月04日在中国获批，其美国专利将于2027年到期，而ULTOMIRIS的成功上市有望将专利延长至2035年。

阵发性夜间血红蛋白尿症（PNH）

阵发性夜间血红蛋白尿症（paroxysmal nocturnal hemoglobinuria, PNH）是一种以补体介导的红细胞破坏（溶血）为特征的罕见血液疾病，由于1个或多个造血干细胞经获得性体细胞PIG-A基因（phosphotidyl inositol glycan complementation group A）突变造成的非恶性的克隆性疾病，PIG-A突变造成糖基磷脂酰肌醇（glycosyl phosphatidyl inositol，GPI）合成异常，导致由GPI锚接在细胞膜上的一组膜蛋白丢失，包括CD16、CD55、CD59等，临床上主要表现为慢性血管内溶血、再生障碍性贫血和反复血栓形成，可引起广泛的衰弱症状和并发症，该病可发生在全身，并导致器官损伤和过早死亡。

长效版依库丽单抗- Ravulizumab

英文名：Ravulizumab

商品名：ULTOMIRIS^TM

Ravulizumab（ALXN1210）是第一款也是目前唯一一款长效型补体抑制剂，它通过抑制终末补体级联反应中的C5蛋白从而防止溶血的发生；C5蛋白是人体免疫系统的一部分，当它不受控制被激活时，会引发PNH、溶血尿毒综合征(aHUS)、抗乙酰胆碱受体(AchR)和抗体阳性重症肌无力等严重罕见病。

在PNH适应症的临床试验中，Ravulizumab与Soliris相比具有非劣性（所有p < 0.0006），PNH患者从每2周用一次依库丽单抗转为每8周用一次Ravulizumab，效果不减，尤其是Ravulizumab正在开发皮下注射制剂，这对Ravulizumab来说具有市场发展潜力。

除已获批的PNH适应症外，Ravulizumab目前也在进行用于溶血尿毒综合征的三期临床试验。另外，针对治疗重症肌无力和皮下注射可行性的临床试验也计划启动。

专利信息

通过检索发现有7篇相关的美国专利和2篇中国同族专利，其中各有1篇专利还未授权。专利中包含通过Fc段基因工程改造提高Fc-FcRn在PH 6.0下的亲和力，延长了抗体半衰期的基因工程方案。

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Electronic Arts pledges free use for five accessibility patents

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