First and only oral on-demand treatment for HAE approved by regulatory authorities in the United Kingdom

A new medicine for HAE, called Ekterly (sebeltralstat), has been approved by the regulatory authorities in the United Kingdom.

After this approval, sebetralstat will continue to be available through the Early Access to Medicines Scheme (EAMS) from the Medicines and Health Regulatory Agency (MHRA) for the treatment of HAE attacks. This scheme enabled healthcare professionals to prescribe the treatment prior to marketing authorization. This situation will continue until KalVista receives a decision from the National Institute for Health and Care Excellence (NICE) for use of sebetralstat under the UK’s National Health Service (NHS). A decision is anticipated in the first half of 2026.

Ben Palleiko, CEO of KalVista, said: “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. 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.”

Dr Sinisa Savic, Professor of Clinical Immunology at St James’s University Hospital Leeds and a sebetralstat investigator, said: “The MHRA approval of Ekterly brings us one step closer to having an oral on-demand treatment available to patients in the UK for the first time. I look forward to seeing the impact this new treatment option will have on the HAE community in the UK.”

(Source: KalVista)