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Drugs

Sebetralstat: First Approval

Published in:
Author
Hannah A. Blair
Published in
Drugs | Issue 11/2025

Abstract

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.
Title
Sebetralstat: First Approval
Author
Hannah A. Blair
Publication date
27-09-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 11/2025
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02239-0
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