FRAMINGHAM, Mass.– KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) said the European Commission and Swissmedic have approved EKTERLY (sebetralstat), the first and only oral on-demand treatment for hereditary angioedema (HAE) attacks in adults and adolescents 12 and older. The company expects to launch the drug in Germany in the fourth quarter of 2025, with availability in Switzerland anticipated in the second half of 2026, pending reimbursement agreements.
EKTERLY, a plasma kallikrein inhibitor, is now cleared in the United States, United Kingdom, European Union and Switzerland, with additional regulatory applications under review worldwide.
“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,” said Henrik Balle Boysen, President of HAE International.
KalVista Chief Executive Officer Ben Palleiko called the approvals “a significant step forward in our efforts to deliver the first and only oral on-demand treatment for HAE to patients around the world.” He added, “With our U.S. 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.”
The European and Swiss approvals are supported by results from the Phase 3 KONFIDENT trial, the largest HAE clinical study to date. The randomized trial enrolled 136 patients across 20 countries and 66 sites, and results were published in the New England Journal of Medicine in May 2024. EKTERLY achieved significantly faster symptom relief, reductions in attack severity and resolution compared to placebo, and was well-tolerated with a safety profile similar to placebo.
“The KONFIDENT trial showed that EKTERLY delivers rapid and reliable symptom relief with a favorable safety profile,” said Danny Cohn, M.D., Ph.D., Head of the HAE clinic at Amsterdam UMC, University of Amsterdam, and principal investigator of the study. “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.”
The European Commission’s decision covers all 27 EU member states as well as Iceland, Liechtenstein and Norway. EKTERLY also maintains its orphan designation in the EU, granting 10 years of market exclusivity.
