KalVista’s sebetralstat application validated by European Medicines Agency

KalVista announced that the European Medicines Agency – EMA – has validated the submission of a Marketing Authorization Application, or MAA, for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema – HAE -. This application will now be reviewed by the EMA’s Committee for Medicinal Products for Human Use under the centralized licensing procedure for all 27 Member States of the European Union, as well as the EEA countries Norway, Iceland and Liechtenstein. The MAA submission was supported by previously disclosed results in which sebetralstat met the primary endpoint for its phase 3 trial with both 300 mg and 600 mg formulations achieving the beginning of symptom relief significantly faster than placebo and was well-tolerated, with a safety profile similar to placebo. In June, KalVista submitted an NDA for sebetralstat to the FDA.