KalVista Pharmaceuticals Receives UK Approval for Ekterly

KalVista Pharmaceuticals has received UK marketing authorization for Ekterly, a treatment for hereditary angioedema attacks in patients aged 12 and older. The approval is based on phase 3 clinical trial results. Ekterly is a plasma inhibitor that aims to reduce swelling in the affected areas.

July 2, 2025 - KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom 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. This approval marks a significant milestone for KalVista as it is the first and only oral on-demand treatment for HAE approved in the UK [1].

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 the trial, published in the New England Journal of Medicine in May 2024, demonstrated that EKTERLY achieved significantly faster symptom relief, reduction in attack severity, and attack resolution compared to placebo, while also being well-tolerated with a safety profile similar to placebo [1].

"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" [1].

EKTERLY also met the requirements of the MHRA Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 10 years of market exclusivity [1].

In March of this year, sebetralstat was granted a positive scientific opinion for an Early Access to Medicines Scheme (EAMS) from the MHRA for the treatment of HAE attacks. This has enabled healthcare professionals to prescribe the treatment prior to marketing authorization, based on clinical factors for patients with a clear unmet need. It will continue to be available through the EAMS until KalVista receives a decision from the National Institute for Health and Care Excellence (NICE) for use of EKTERLY under the UK’s National Health Service (NHS), which is anticipated in the first half of 2026 [1].

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 [1].

References:
[1] https://www.businesswire.com/news/home/20250715103754/en/KalVista-Pharmaceuticals-Announces-UK-MHRA-Approval-of-EKTERLY-sebetralstat-First-and-Only-Oral-On-demand-Treatment-for-Hereditary-Angioedema