KalVista Pharmaceuticals (NASDAQ: KALV) 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 EU and Switzerland.
In a statement, Henrik Balle Boysen, president of HAE International, commented, “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, added, “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. This continued progress underscores the strength of our science and reinforces the potential of EKTERLY to become the foundational treatment for HAE worldwide.”
