KalVista announces MHRA approval of Ekterly

KalVista (KALV) Pharmaceuticals announced that the Medicines and Healthcare products Regulatory Agency of the United Kingdom has granted marketing authorization for EKTERLY, a novel plasma kallikrein inhibitor, for the treatment of hereditary angioedema 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. “The approval of EKTERLY in the United Kingdom builds on our recent FDA approval and advances our global commitment to bring this innovative treatment option to people living with HAE,” said Ben Palleiko, CEO of KalVista. “This approval holds particular significance for KalVista as EKTERLY was discovered in our Salisbury, UK labs-making it even more exciting that now we will be able to offer this therapy to people living with HAE in the UK. More broadly, this is another example of the incredible skills of our entire team in pursuing what we expect to be the fastest global launch of an HAE therapy ever.” The MHRA’s marketing authorization for EKTERLY is based on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical study ever conducted in HAE. Data from KONFIDENT was published in the New England Journal of Medicine in May 2024, showing that EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo. The trial randomized 136 HAE patients from 66 clinical sites across 20 countries.