Posted by Michael Wonder on 07 Sep 2024
KalVista announces FDA acceptance of new drug application for sebetralstat for oral on-demand treatment of hereditary angioedema
3 September 2024 - FDA PDUFA goal date of 17 June 2025.
KalVista Pharmaceuticals today announced that the US 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 paediatric patients aged 12 years and older.
