NMPA批准Uplizna(伊奈利珠单抗)治疗视神经脊髓炎谱系疾病(NMOSD)

2022-03-14 网络 网络

2022年03月11日,中国国家药监局(NMPA)官网最新公示, 抗CD19单克隆抗体伊奈利珠单抗(inebilizumab)获批上市用于治疗视神经脊髓炎谱系疾病(NMOSD)患者。

2022年03月11日,中国国家药监局(NMPA)官网最新公示, 抗CD19单克隆抗体伊奈利珠单抗(inebilizumab)获批上市用于治疗视神经脊髓炎谱系疾病(NMOSD)患者。

伊奈利珠单抗(inebilizumab,Uplizna)是一款 由Viela Bio(已被Horizon Therapeutics收购)开发的对CD19具有高度亲和力的人源化单克隆抗体,通过与CD19抗原结合,可以迅速将这些细胞从血循环中清除,从而降低自身抗体的产生,进而达到改善患者症状的目的。CD19是在B细胞癌症中广泛表达的抗原,它能够增强B细胞受体介导的信号通路,支持B细胞生存,是靶向B细胞癌症的重要靶点。研究显示,CD19表达在多类B细胞上,其中包括分泌抗体的成浆细胞和浆细胞。

国内首款 CD19 单抗,Inebilizumab 是一款对 CD19 具有高度亲和力的人源化单克隆抗体。目前,国内尚未有 CD19 单抗获批上市,Inebilizumab 为国内首款、也是当前唯一一款报上市的 CD19 单抗。

2019 年 2 月,Inebilizumab 获得了美国 FDA 授予的突破性疗法认定,并获得孤儿药资格,治疗罕见自身免疫疾病视神经脊髓炎谱系障碍(NMOSD)。2020 年 6 月,Inebilizumab 获 FDA 批准上市,商品名为 Uplizna。

2019 年 5 月 28 日,豪森药业与 Viela Bio 达成了战略合作,在中国开发 Inebilizumab 治疗 NMOSD 以及其他潜在的炎症/自身免疫和血液学恶性肿瘤适应症。根据协议条款,Viela Bio 有资格获得一笔前期合作费用和超过 2.2 亿美元的里程碑付款,以及基于产品净销售的分层版税,豪森药业则负责领导在中国开发和商业化 Inebilizumab。

Inebilizumab 全球适应症开发进度

图片Inebilizumab 是 FDA 批准的第二款 NMOSD 治疗药物。目前,该疾病领域 FDA 已批准三款抗体药,另外两款分别为 Alexion 公司的 C5 抗体依库珠单抗(Eculizumab,商品名 Soliris)和罗氏的 IL-6 单抗萨特利珠单抗(Satralizumab),前者在国内尚未获批 NMOSD 适应症,后者于 2021 年 4 月在国内获批上市,商品名为安适平。

NMOSD 是一种罕见、严重、复发性的神经炎症性自身免疫疾病,以视神经和脊髓的炎性病变为特征。2018 年 5 月被纳入国家 121 种罕见病目录。NMOSD 全球总患病率为 1.82/10 万,多见于亚洲患者,发病时平均年龄为 32.6-45.7 岁,且女性多发。患者时刻担心疾病复发,每次复发都可能会让他们丧失视觉、行动能力甚至生命,给患者及家庭带来极大的经济负担和心理负担。

Inebilizumab 在美国上市基于一项评估 Uplizna 疗效和安全性的 N-MOmentum 临床试验。该试验入组 230 位成年患者,其中有 213 名患者呈抗 AQP4 抗体阳性。为期 197 天的研究显示,与安慰剂治疗组相比,接受 Uplizna 治疗的 161 名抗 AQP4 抗体阳性患者的 NMOSD 复发风险降低了 77%。

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    2023-02-02 xlysu
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    2022-03-29 gj0740
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    2022-03-16 AspirantSuo
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    2022-03-14 医者仁者

    #视神经脊髓炎谱系疾病#终于有治疗药物了

    0

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    2022-03-14 仁术2021

    不错,学习了

    0

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脊髓受累是视神经脊髓炎谱系疾病(NMOSD)的核心特征。传统上,急性脊髓损伤至少涉及三个连续的椎体节段,但也同时也可观察到较短的损伤。

NEJM:Satralizumab治疗视神经脊髓炎谱系疾病的SAkuraSky III期研究取得喜人结果

日本中外制药株式会社宣布,有关satralizumab的全球III期SAkuraSky研究(NCT02028884)的结果已于11月27日在NEJM在线发表。Satralizumab是一种抗IL6受体抗体,正在开发用于治疗视神经脊髓炎谱系疾病(NMOSD)。

NEJM:Eculizumab治疗可降低AQP4-IgG阳性的NMOSD患者复发风险

在AQP4-IgG阳性的NMOSD患者中,接受Eculizumab治疗可降低复发风险

Lancet:Inebilizumab可降低视神经脊髓炎谱系疾病 (NMOSD)发作风险

研究认为,与安慰剂相比,Inebilizumab降低了NMOSD发作风险

Lancet Neurology:托珠单抗与硫唑嘌呤治疗高度复发性视神经脊髓炎频谱障碍(TANGO)的安全性和有效性:一项开放性、多中心、随机、2期试验

视神经脊髓炎(NMOSD)是一种严重的中枢神经系统致残性炎症性自身免疫性疾病,常伴有水通道蛋白-4(AQP-4)的病理性体液免疫反应。这种疾病最常见的特征是反复复发的视神经炎和纵向广泛的横向脊髓炎。

JNNP:视神经脊髓炎谱系疾病:与妊娠有关的发作和预测危险因素

视神经脊髓炎谱系障碍(NMOSD)反映了自身抗体诱导的中枢神经系统(CNS)炎症性疾病的分类,主要涉及视神经、脊髓,血清中存在致病性水通道蛋白-4抗体(AQP4-ab)对NMOSD具有高度特异性,在大