KalVista Pharmaceuticals Announces Approval of EKTERLY® (sebetralstat) in Japan, First and Only Oral On-demand Treatment for Hereditary Angioedema

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[{"type":"text","content":" FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the 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 approved in Japan.\n\n\nEKTERLY will be commercialized in Japan by KalVista’s partner, Kaken Pharmaceutical Co., Ltd. Kaken will launch EKTERLY shortly after it is listed on the Japanese National Health Insurance System (NHI).\n\n\n“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, CEO 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.”\n\n\nIn December 2024, KalVista received Orphan Drug designation for EKTERLY in Japan. The approval is based on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical study ever conducted in HAE. Data from KONFIDENT were 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. The trial randomized 136 HAE patients from 66 clinical sites across 20 countries.\n\n\nSince July 3, 2025, EKTERLY has received seven regulatory approvals across major global markets, including in the United States, United Kingdom, European Union, Switzerland, Australia, Singapore, and Japan. Each approval authorizes its use for treating HAE attacks in individuals aged 12 and older.\n\n\nAbout Hereditary Angioedema\n\n\nHereditary angioedema (HAE) is a rare genetic disease resulting in d...

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