Approval of sebetralstat by Japanese regulatory authority

A new medicine for HAE, called Ekterly (sebetralstat), has been granted marketing and manufacturing approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

Sebetralstat is the first and only oral on-demand treatment for HAE approved in Japan, and will be commercialized in Japan by KalVista’s partner, Kaken Pharmaceutical. Kaken will launch sebetralstat shortly after it is listed on the Japanese National Health Insurance System (NHI).

Ben Palleiko, CEO of KalVista, said: “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. 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.”

Since 3 July 2025, sebetralstat has received seven regulatory approvals across major global markets, including in the United States, United Kingdom, European Union, Switzerland, Australia, Singapore, and now Japan. Each approval authorizes its use for treating HAE attacks in individuals aged 12 and older.

(Source: KalVista)