Blair Hannah A
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Paediatr Drugs. 2025 Jan;27(1):119-124. doi: 10.1007/s40272-024-00668-0.
Apremilast (Otezla) is an inhibitor of phosphodiesterase-4 (PDE-4) being developed by Amgen. It is approved in multiple countries worldwide, including the USA and those of the EU, for the treatment of adults with psoriatic arthritis, plaque psoriasis, or oral ulcers associated with Behçet's disease. In April 2024, based on clinical data in patients aged 6-17 years, apremilast received its first pediatric approval in the USA for the treatment of pediatric patients aged ≥ 6 years and weighing ≥ 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Apremilast was also approved in the EU in October 2024 for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing ≥ 20 kg who are candidates for systemic therapy. This article summarizes the milestones in the development of apremilast leading to the first pediatric approval for plaque psoriasis.
阿普米司特（欧泰乐）是安进公司正在研发的一种磷酸二酯酶-4（PDE-4）抑制剂。它在全球多个国家获得批准，包括美国和欧盟国家，用于治疗患有银屑病关节炎、斑块状银屑病或与白塞病相关口腔溃疡的成人患者。2024年4月，基于6至17岁患者的临床数据，阿普米司特在美国首次获得儿科批准，用于治疗年龄≥6岁且体重≥20千克、适合光疗或全身治疗的中度至重度斑块状银屑病儿科患者。阿普米司特于2024年10月在欧盟也获得批准，用于治疗年龄6岁及以上、体重≥20千克、适合全身治疗的儿童和青少年中度至重度斑块状银屑病。本文总结了阿普米司特在斑块状银屑病首次获得儿科批准之前的研发历程中的重要节点。
