Press release
KalVista Pharmaceuticals Receives Positive CHMP Opinion for Sebetralstat for the Treatment of Hereditary Angioedema Attacks
If approved, sebetralstat will be the first and only oral on-demand treatment for HAE in the European Union (EU) European Commission decision expected by
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\nIf approved, sebetralstat will be the first and only oral on-demand treatment for HAE in the European Union (EU)\n\n\nEuropean Commission decision expected by early October 2025\n\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for sebetralstat, a novel oral plasma kallikrein inhibitor, for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The European Commission (EC) final decision is expected by early October.\n\n\n“This positive CHMP opinion is an important step forward for people living with HAE in Europe, where there remains a high need for effective, easy-to-administer on-demand treatments,” said Ben Palleiko, CEO of KalVista. “Coming just weeks after regulatory approvals in the US and UK, this milestone highlights the potential of sebetralstat to transform how HAE is managed globally. Sebetralstat is expected to become the first and only oral on-demand treatment for HAE available in Europe, bringing forward a new treatment approach that enables adherence to guidelines and empowers people to treat attacks quickly, wherever they occur.”\n\n\nThe CHMP based its opinion on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical trial ever conducted in HAE. Data from KONFIDENT was published in the New England Journal of Medicine in May 2024, showing that sebetralstat 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“Access to on-demand treatments that offer easy self-administration and rapid symptom relief is critical for patients living with HAE,” said Emel Aygören-Pürsün, M.D., Assistant Professor, Internal Medicine and Hemostaseology, Department for Children and Adolescents, University Hospital Frankfurt. “Until now, on-demand therapies for HAE attacks required parenteral administration via injections. The positive CHMP opinion for sebetralstat is an essential move toward a ...