KalVista Pharmaceuticals (KALV) said Tuesday that Japan's Ministry of Health, Labour and Welfare granted Orphan Drug Designation for sebetralstat and accepted its New Drug Application for the treatment of hereditary angioedema.
The company said the application is based on results from a late-stage trial that evaluated the safety and efficacy of sebetralstat.
KalVista said it is conducting an extension trial with a new oral disintegrating tablet formulation, aiming for a supplementary filing next year.
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