KalVista announces FDA approval of NDA for sebetralstat

KalVista Pharmaceuticals announced that the U.S. FDA has accepted its New Drug Application for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adult and pediatric patients aged 12 years and older. The FDA has set a Prescription Drug User Fee Act goal date of June 17, 2025. If approved, sebetralstat would be the first oral, on-demand treatment for HAE in adult and pediatric patients aged 12 years and older. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.