Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2022 Jul;82(10):1143-1150. doi: 10.1007/s40265-022-01741-z. Epub 2022 Jul 14.
Nemolizumab is a subcutaneously administered humanized anti-interleukin-31 (IL-31) receptor A (IL-31RA) monoclonal antibody that is being developed by Chugai Pharmaceutical Co. Ltd, Maruho Co. Ltd and Galderma Pharma S.A. for the treatment of skin diseases, including atopic dermatitis (AD), AD associated pruritus (ADaP), prurigo nodularis (PN), chronic kidney disease associated pruritus (CKDaP) and systemic sclerosis (SSc). IL-31 is a neuroimmune cytokine that induces itch, inflammation, keratinocyte differentiation and fibroblast activation in chronic pruritic skin diseases. Nemolizumab (Mitchga Syringes) was approved in Japan on 28 March 2022 for use in adults and children over the age of 13 years for the treatment of itch associated with AD (only when existing treatment is insufficiently effective). This article summarizes the milestones in the development of nemolizumab leading to this first approval.
内莫利珠单抗是一种皮下注射用的人源化抗白细胞介素-31（IL-31）受体 A（IL-31RA）单克隆抗体，由中外制药有限公司、丸红株式会社和高德美制药有限公司开发，用于治疗皮肤病，包括特应性皮炎（AD）、AD 相关瘙痒（ADaP）、结节性痒疹（PN）、慢性肾脏病相关瘙痒（CKDaP）和系统性硬化症（SSc）。IL-31 是一种神经免疫细胞因子，可在慢性瘙痒性皮肤病中引起瘙痒、炎症、角质形成细胞分化和成纤维细胞激活。内莫利珠单抗（Mitchga 注射器）于 2022 年 3 月 28 日在日本获批上市，用于治疗 AD 相关瘙痒（仅在现有治疗方法效果不足时使用），适用于 13 岁及以上的成人和儿童。本文总结了内莫利珠单抗研发过程中的重要里程碑，直至首次获批。
