Approval of sebetralstat from European Union and Swiss regulatory authorities

A new medicine for HAE, called Ekterly (sebetralstat), has received approval from the European Commission (EC) and the Swiss Agency for Therapeutic Products, Swissmedic, for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

The EC approval is applicable to all 27 EU member states as well as Iceland, Liechtenstein and Norway. KalVista is working closely with local regulatory authorities and health technology assessment bodies across the EU and Switzerland to help ensure that patients who may benefit from sebetralstat are able to access the novel treatment as soon as possible. The Company expects the first European country to launch will be Germany in the fourth quarter of 2025, with availability in Switzerland anticipated in the second half of 2026, pending finalization of reimbursement plans.

Henrik Balle Boysen, President of HAEi, said: “As the first orally administered on-demand therapy for HAE attacks, Ekterly provides patients and physicians with an important and welcome new HAE treatment option.”

Ben Palleiko, CEO of KalVista, said: “The approval of Ekterly in Europe and Switzerland is a significant step forward in our efforts to deliver the first and only oral on-demand treatment for HAE to patients around the world. With our US launch progressing well and approvals now secured in the UK, EU and Switzerland, we look forward to bringing this innovation to more people living with HAE, beginning with our first European launch in Germany.”

Danny Cohn MD PhD, Head of the HAE clinic at Amsterdam UMC, University of Amsterdam, Netherlands and principal investigator for the KONFIDENT phase 3 trial, said: “The KONFIDENT trial showed that Ekterly delivers rapid and reliable symptom relief with a favorable safety profile. With today’s approvals, this innovation can now be brought into clinical practice, empowering patients and clinicians across Europe and Switzerland with the first oral on-demand treatment for HAE.”

(Source: KalVista)