Posted by Michael Wonder on 20 Jun 2024
KalVista submits new drug application to FDA for sebetralstat as first oral on-demand treatment for hereditary angioedema
18 June 2024 - KalVista Pharmaceuticals today announced the submission of a new drug application for US FDA review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and paediatric patients aged 12 years and older.
The new drug application submission is based on previously disclosed clinical trial results, including data from the KONFIDENT Phase 3 clinical trial and the KONFIDENT-S extension trial.
