Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2023 Apr;83(5):455-459. doi: 10.1007/s40265-023-01854-z.
Ublituximab (ublituximab-xiiy; BRIUMVI) is a glycoengineered anti-CD20 monoclonal antibody developed by TG Therapeutics, Inc. for the treatment of multiple sclerosis (MS). The mechanism of action of ublituximab involves the depletion of B cells via antibody-dependent cellular cytotoxicity, as B cells have a key role in the pathogenesis of MS. Ublituximab is the first anti-CD20 treatment that is administered twice-yearly as one hour infusions, following the initial doses. In December 2022, ublituximab received its first global approval in the USA for the treatment of adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This article summarizes the milestones in the development of ublituximab leading to this first approval in this indication.
乌利昔单抗（ublituximab-xiiy；BRIUMVI）是一种糖基化工程抗 CD20 单克隆抗体，由 TG Therapeutics, Inc. 开发，用于治疗多发性硬化症（MS）。乌利昔单抗的作用机制涉及通过抗体依赖性细胞毒性来耗竭 B 细胞，因为 B 细胞在 MS 的发病机制中起关键作用。乌利昔单抗是首个每半年一次给药、每次 1 小时输注的抗 CD20 治疗药物，初始剂量除外。2022 年 12 月，乌利昔单抗在美国获得首个全球批准，用于治疗成人复发型 MS，包括临床孤立综合征、复发缓解型疾病和活动性继发进展型疾病。本文总结了乌利昔单抗在这一适应证中首次获批的开发里程碑。
