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

About this update from Kalvista Pharmaceuticals, Inc.

[{"type":"text","content":" CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today 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 countries Norway, Iceland and Liechtenstein.\n\n\n“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,” said Ben Palleiko, Chief Executive Officer of KalVista. “If approved, sebetralstat would be the first oral, on-demand treatment for HAE in Europe. We believe it has the potential to become the foundational treatment for this disease, addressing many underlying unmet needs in the community.”\n\n\nThe MAA submission was supported by previously disclosed results, including data from the KONFIDENT phase 3 clinical trial and ongoing KONFIDENT-S open label extension trial. 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 (p","length":1965,"tagName":"div"}]

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