FRAMINGHAM, Mass.– KalVista Pharmaceuticals, Inc. said Japan’s Ministry of Health, Labor and Welfare has granted marketing and manufacturing approval for EKTERLY (sebetralstat) for the treatment of acute attacks of hereditary angioedema in adults and adolescents aged 12 and older.
The approval makes EKTERLY the first and only oral on-demand treatment for hereditary angioedema authorized in Japan. The drug is a novel plasma kallikrein inhibitor designed to provide rapid relief during acute HAE attacks.
EKTERLY will be commercialized in Japan by KalVista’s partner, Kaken Pharmaceutical Co., Ltd., with a launch planned shortly after the therapy is listed on Japan’s National Health Insurance system.
“The approval of EKTERLY in Japan marks another major milestone in our global pursuit to bring the first and only oral on-demand treatment to people living with HAE,” said Ben Palleiko, chief executive officer of KalVista. “We recognize the significant efforts of our Japanese team in achieving this outcome. We also appreciate the diligent commercial preparations by Kaken and look forward to their continued leadership in making this therapy available to patients in Japan. This approval underscores both the urgent need for new, effective therapies and the potential of EKTERLY to meaningfully improve the lives of individuals and families affected by HAE across the world.”
KalVista received orphan drug designation for EKTERLY in Japan in December 2024. The approval was based on data from the phase 3 KONFIDENT clinical trial, the largest clinical study ever conducted in hereditary angioedema. Results from the trial were published in The New England Journal of Medicine in May 2024.
In the KONFIDENT study, EKTERLY demonstrated significantly faster symptom relief, reduced attack severity, and quicker attack resolution compared with placebo. The treatment was generally well tolerated, with a safety profile similar to placebo. The trial enrolled 136 patients across 66 clinical sites in 20 countries.
Since July 3, 2025, EKTERLY has received seven regulatory approvals across major global markets, including the United States, United Kingdom, European Union, Switzerland, Australia, Singapore, and Japan. Each approval authorizes its use for the treatment of hereditary angioedema attacks in patients aged 12 and older.
