Sebetralstat：首次批准。

IF 14.4 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2025-09-27 DOI:10.1007/s40265-025-02239-0

Hannah A Blair

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引用次数: 0

摘要

Sebetralstat （ektly®）是一种口服血浆钾likrein抑制剂，由KalVista制药公司开发，用于遗传性血管性水肿（HAE）急性发作的按需治疗。2025年7月7日，sebetralstat在美国首次获得批准，用于治疗12岁及以上成人和儿童HAE急性发作。该药于2025年7月15日在英国被批准用于治疗12岁及以上的成人和青少年HAE发作。Sebetralstat在欧盟用于12岁及以上成人和青少年HAE急性发作的对症治疗也获得了积极的评价。本文总结了sebetralstat首次获批用于HAE的发展历程。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Sebetralstat: First Approval.

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.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.