Japan Approves KalVista's EKTERLY as First Oral On-Demand HAE Treatment

Reuters

2025/12/22

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Kalvista Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251222393408) on December 22, 2025, and is solely responsible for the information contained therein.

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While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. <a href=\"https://laohu8.com/S/KALV\">Kalvista Pharmaceuticals Inc</a>. published the original content used to generate this news brief via Business Wire (Ref. 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