Press release
KalVista Pharmaceuticals Announces European Commission and Swissmedic Approval of EKTERLY® (sebetralstat), First and Only Oral On-Demand Treatment for Hereditary Angioedema
First European launch of EKTERLY expected in Germany Q4 2025 EKTERLY now approved in the US, EU, UK and Switzerland with additional regulatory applications
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\nFirst European launch of EKTERLY expected in Germany Q4 2025\n\n\nEKTERLY now approved in the US, EU, UK and Switzerland with additional regulatory applications under review in key global markets\n\n\n FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the European Commission (EC) and Swiss Agency for Therapeutic Products, Swissmedic, have approved EKTERLY® (sebetralstat), a novel, oral plasma kallikrein inhibitor, for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE in the European Union (EU) and Switzerland.\n\n\n“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.\n\n\n“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,” said Ben Palleiko, CEO of KalVista. “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. This continued progress underscores the strength of our science and reinforces the potential of EKTERLY to become the foundational treatment for HAE worldwide.”\n\n\nThe EC and Swissmedic marketing authorizations for EKTERLY are based on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical study ever conducted in HAE. Data from KONFIDENT was published in the New England Journal of Medicine in May 2024, showing that EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo.1 The trial randomized 136 HAE patients from 66 clinical sites across 20 countries.\n\n\n“The KONFIDENT trial showed that EKTERLY delivers rapid and reliable symptom relief with a favorable safety profile,” said Danny Cohn, MD, PhD, Head of the HAE clinic at Amsterdam UMC, University of Amsterdam, Netherlands and principa...