Japan Approves KalVista's EKTERLY as First Oral On-Demand HAE Treatment
Reuters
Dec 22, 2025
Japan Approves KalVista's EKTERLY as First Oral On-Demand HAE Treatment
KalVista Pharmaceuticals Inc. has announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for EKTERLY® (sebetralstat), the first and only oral on-demand treatment for hereditary angioedema $(HAE)$ in adults and adolescents aged 12 years and older. This approval follows EKTERLY’s Orphan Drug designation in Japan and is based on results from the phase 3 KONFIDENT clinical trial, which demonstrated significant efficacy and a favorable safety profile. EKTERLY has now received regulatory approvals in seven major markets, including the United States, United Kingdom, European Union, Switzerland, Australia, Singapore, and Japan. The therapy will be commercialized in Japan by KalVista’s partner, Kaken Pharmaceutical Co., Ltd.
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