Blair Hannah A
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2025 Nov;85(11):1499-1505. doi: 10.1007/s40265-025-02239-0. Epub 2025 Sep 27.
Sebetralstat (EKTERLY), an orally available plasma kallikrein inhibitor, is being developed by KalVista Pharmaceuticals for the on-demand treatment of acute attacks of hereditary angioedema (HAE). On 7 July 2025, sebetralstat received its first approval in the USA for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older. The drug has since been approved on 15 July 2025 in the UK for the treatment of HAE attacks in adults and adolescents aged 12 years and older. Sebetralstat has also received a positive opinion in the EU for the symptomatic treatment of acute attacks of HAE in adults and adolescents aged 12 years and older. This article summarizes the milestones in the development of sebetralstat leading to this first approval for HAE.
塞贝司他（EKTERLY）是一种口服可用的血浆激肽释放酶抑制剂，由KalVista制药公司开发，用于按需治疗遗传性血管性水肿（HAE）急性发作。2025年7月7日，塞贝司他在美国首次获批，用于治疗12岁及以上成人和儿童患者的HAE急性发作。此后，该药物于2025年7月15日在英国获批，用于治疗12岁及以上成人和青少年的HAE发作。塞贝司他在欧盟也获得了积极意见，用于12岁及以上成人和青少年HAE急性发作的对症治疗。本文总结了塞贝司他开发过程中导致其首次获批用于HAE的里程碑事件。
