Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2020 Aug;80(12):1259-1264. doi: 10.1007/s40265-020-01370-4.
Inebilizumab (Uplizna™; inebilizumab-cdon in the USA) is a humanised anti-CD19 monoclonal antibody being developed by Viela Bio for the treatment of a range of autoimmune diseases associated with CD19-expressing B cells. Inebilizumab targets and depletes CD19-expressing B cells through antibody-dependent cell-mediated cytotoxicity. In June 2020, inebilizumab received its first global approval in the USA for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are seropositive for immunoglobulin G autoantibodies against aquaporin-4 (AQP4-IgG). The drug is also undergoing clinical evaluation for kidney transplant desensitization, myasthenia gravis, and IgG4-related disease. This article summarizes the milestones in the development of inebilizumab leading to this first approval for the treatment of AQP4-IgG seropositive NMOSD.
依那西普单抗（Uplizna™；在美国称为 inebilizumab-cdon）是一种人源化抗 CD19 单克隆抗体，由 Viela Bio 公司开发，用于治疗一系列与表达 CD19 的 B 细胞相关的自身免疫性疾病。依那西普单抗通过抗体依赖性细胞介导的细胞毒性作用靶向并耗尽表达 CD19 的 B 细胞。2020 年 6 月，依那西普单抗在美国获得首次全球批准，用于治疗抗水通道蛋白 4（AQP4-IgG）自身抗体阳性的成年患者的视神经脊髓炎谱系障碍（NMOSD）。该药物也正在进行临床试验，用于肾移植脱敏、重症肌无力和 IgG4 相关疾病的治疗。本文总结了依那西普单抗开发过程中的重要里程碑，最终使其获得了治疗抗 AQP4-IgG 阳性 NMOSD 的首次批准。
