KalVista Pharmaceuticals Receives UK MHRA Approval for EKTERLY®, the First Oral On-Demand Treatment for Hereditary Angioedema
Wednesday, July 16, 2025
KalVista Pharmaceuticals, Inc. has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for EKTERLY® (sebetralstat) for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. EKTERLY is now the first and only oral on-demand therapy approved for HAE in the United Kingdom.
This approval follows the recent authorisation of EKTERLY by the United States Food and Drug Administration (FDA) and reflects KalVista’s ongoing global efforts to improve treatment options for people living with HAE. EKTERLY was originally discovered in KalVista’s research facilities in Salisbury, UK, marking a significant milestone for the company and highlighting the capabilities of its scientific teams.
The MHRA's decision is based on findings from the Phase 3 KONFIDENT trial, the largest clinical study to date in hereditary angioedema. The study, which included 136 patients from 66 clinical sites across 20 countries, demonstrated that sebetralstat provided faster symptom relief, reduced attack severity, and improved resolution compared to placebo. The treatment was also well-tolerated, with a safety profile similar to placebo. Results from the trial were published in the New England Journal of Medicine in May 2024.
EKTERLY has also met the criteria for orphan designation by the MHRA and will be included in the UK’s Orphan Register, making it eligible for up to 10 years of market exclusivity.
Earlier this year, in March, the MHRA issued a positive scientific opinion for EKTERLY under the Early Access to Medicines Scheme (EAMS), allowing healthcare providers to prescribe the treatment before formal marketing approval for patients with a clear unmet clinical need. EKTERLY will remain available through the EAMS until a decision is issued by the National Institute for Health and Care Excellence (NICE) regarding its use under the NHS. This decision is expected in the first half of 2026.
In addition to approvals in the UK and the US, KalVista has submitted regulatory applications for sebetralstat in the European Union, Japan, and other key global markets.
Source: businesswire.com
