KalVista Pharmaceuticals Inc. (KALV) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE approved in the UK.
On July 3, 2025, EKTERLY was approved by the U.S. Food and Drug Administration for the treatment of HAE attacks in people 12 years of age and older. KalVista has submitted marketing authorization applications for sebetralstat in the EU, Japan and other key global markets.
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