KalVista Announces Validation of MAA by the EMA for Sebetralstat for HAE

KalVista Announces Validation of Marketing Authorization Application by the European Medicines Agency for Sebetralstat for Hereditary Angioedema

KalVista Pharmaceuticals announced that the European Medicines Agency (EMA) has validated the submission of a Marketing Authorization Application (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 (CHMP) under the centralized licensing procedure for all 27 Member States of the European Union, as well as the EEA

Ben Palleiko, Chief Executive Officer of KalVista, said: “The validation of this MAA, which we submitted in July, brings us another step closer to our goal of delivering sebetralstat on a global scale to people living with HAE. If approved, sebetralstat would be the first oral, on-demand treatment for HAE in Europe.”

(Source: KalVista)