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Drugs. 2021 Dec;81(18):2149-2157. doi: 10.1007/s40265-021-01638-3.
Abrocitinib (Cibinqo) is an oral small-molecule inhibitor of Janus kinase 1 (JAK1) being developed by Pfizer for the treatment of moderate-to-severe atopic dermatitis (AD). In September 2021, abrocitinib was approved in the UK and Japan for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Abrocitinib has also received a positive CHMP opinion in the EU for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Regulatory applications for the drug have also been submitted for review to several other countries, including the USA and Australia. This article summarizes the milestones in the development of abrocitinib leading to this first approval for the treatment of moderate-to-severe AD.
阿布昔替尼（Cibinqo）是辉瑞公司开发的一种口服小分子 Janus 激酶 1（JAK1）抑制剂，用于治疗中重度特应性皮炎（AD）。2021 年 9 月，阿布昔替尼在英国和日本获批用于治疗中重度 AD，适用于候选系统性治疗的成人和 12 岁及以上青少年。阿布昔替尼在欧盟也获得了积极的 CHMP 意见，用于治疗候选系统性治疗的中重度特应性皮炎成人患者。该药物的监管申请也已提交给包括美国和澳大利亚在内的其他几个国家进行审查。本文总结了导致阿布昔替尼首次获批用于治疗中重度 AD 的开发里程碑。
