KalVista Secures UK Approval for EKTERLY, a Novel Oral On-Demand Treatment for Hereditary Angioedema.

KalVista Pharmaceuticals has received UK approval for EKTERLY, the first oral on-demand treatment for hereditary angioedema (HAE). EKTERLY, a plasma kallikrein inhibitor, has been approved for adults and adolescents aged 12 and older. KalVista has submitted marketing authorization applications for the treatment in the EU, Japan, and other key global markets. EKTERLY was previously approved by the US FDA in July 2025.

KalVista Pharmaceuticals Inc. (KALV) has received a significant milestone in its mission to improve the lives of individuals affected by hereditary angioedema (HAE). 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 HAE attacks in adults and adolescents aged 12 years and older [1]. This approval marks the first and only oral on-demand treatment for HAE in the UK.

The approval of EKTERLY in the UK follows its successful FDA approval in the United States on July 3, 2025 [3]. KalVista has also submitted marketing authorization applications for sebetralstat in the EU, Japan, and other key global markets, further expanding its reach to bring this innovative treatment option to patients worldwide [1, 2].

EKTERLY is the result of extensive clinical trials, including the phase 3 KONFIDENT study, which demonstrated significant improvements in symptom relief, attack severity reduction, and resolution compared to placebo, with a well-tolerated safety profile [2]. The MHRA's approval of EKTERLY brings it one step closer to becoming available to patients in the UK through the National Health Service (NHS) [2].

This approval is a notable achievement for KalVista, as EKTERLY was discovered in their Salisbury, UK labs, highlighting the company's commitment to developing life-changing oral therapies for rare diseases with significant unmet needs [2]. The company's focus on delivering EKTERLY to those who need it underscores its dedication to the HAE community.

The approval of EKTERLY in the UK is expected to have a substantial impact on the lives of people living with HAE, providing them with an oral on-demand treatment option that offers rapid symptom relief and attack resolution, regardless of attack severity, location, age, or use of long-term prophylaxis [3].

KalVista's success with EKTERLY is a testament to its scientific rigor and commitment to the HAE community. As the company continues to pursue regulatory approvals in key global markets, investors can expect to see further developments in the company's efforts to transform the management of HAE.

References:
[1] https://www.nasdaq.com/articles/kalvista-secures-uk-approval-ekterly-first-oral-demand-treatment-hereditary-angioedema
[2] https://www.stocktitan.net/news/KALV/kal-vista-pharmaceuticals-announces-uk-mhra-approval-of-ekterly-e4hzc383m2rh.html
[3] https://quantisnow.com/insight/kalvista-pharmaceuticals-announces-fda-approval-of-ekterly%C2%AE-sebetralstat-first-and-only-oral-ondemand-treatment-6111978