KalVista (KALV) announced that Japan’s Ministry of Health, Labour and Welfare, or MHLW, has granted sebetralstat orphan drug designation. The company has also submitted a new drug application for sebetralstat to the agency. If approved, sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and adolescents aged 12 years and older, would be the first oral on-demand treatment for HAE in Japan.
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