KalVista announces orphan drug designation and nda submission for sebetralstat in Japan for hereditary angioedema
KalVista Pharmaceuticals announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted sebetralstat Orphan Drug Designation. The Company has also submitted a New Drug Application (NDA) for sebetralstat to the Agency. If approved, sebetralstat would be the first oral on-demand treatment for HAE in Japan.
Ben Palleiko, CEO of KalVista, said: “The submission of our NDA for sebetralstat in Japan represents another key step toward our efforts to make this important new treatment available to as many people living with HAE as possible. The Orphan Drug Designation not only acknowledges the critical need for new, effective treatments for HAE in Japan but underscores the potential of sebetralstat to provide meaningful relief for people who have faced ongoing challenges with existing options. We are proud to be at the forefront of advancing care for the HAE community.”
The NDA submission is supported by previously disclosed results, including data from the KONFIDENT phase 3 clinical trial and ongoing KONFIDENT-S open-label extension trial.
(Source: KalVista)
