The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 15 July 2025, approved sebetralstat (Ekterly) for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.
15 July 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 15 July 2025, approved sebetralstat (Ekterly) for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.
Sebetralstat is the first and only MHRA-approved oral, on-demand treatment for HAE. It is taken as soon as symptoms begin, giving patients the ability to treat the attacks as soon as they start, wherever they are, without the need for injections.
HAE is a rare genetic condition that can cause sudden and painful swelling in various parts of the body, including the face, throat, abdomen, and limbs. Attacks can be unpredictable and, in some cases, life-threatening if they affect the airways.
Sebetralstat works by blocking a natural process in the body to prevent the release of a substance called bradykinin, which makes blood vessels leak fluid, causing swelling. Sebetralstat will help stop the attack from getting worse.
This medicine is administered in tablet form, taken orally at the earliest sign of an attack.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:
"Patient safety is our top priority, which is why we are pleased to approve sebetralstat for the treatment of hereditary angioedema attacks (HAE).
"HAE attacks can have a sudden and serious impact on people's lives, often requiring immediate intervention.
"This approval is the first and only MHRA-approved oral option for treating HAE attacks, which will be valuable for patients who prefer not to use injectable treatments. As with all licensed medicines, we will continue to monitor its safety closely."
Sebetralstat's approval is supported by the KONFIDENT clinical trial, in which 110 patients experienced and treated 264 hereditary angioedema attacks. The study showed that sebetralstat significantly reduced the time from attack to beginning of symptom relief and full attack resolution compared to placebo.
Like all medicines, sebetralstat can cause side effects. The most common adverse reaction in patients treated with sebetralstat is a headache. Other reported side effects include dyspepsia, nausea, abdominal pain, fatigue, back pain, and hot flushes.
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be available on the MHRA website within 7 days of approval.
Anyone who suspects they are having a side effect from this medicine should talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either at www.mhra.gov.uk/yellowcard or via the MHRA Yellow Card app (available on Google Play or the Apple App Store).
Notes
The new marketing authorisation was granted on 15 July to KalVista Pharmaceuticals Ltd.
Sebetralstat (Ekterly) is indicated for the treatment of hereditary angioedema attacks in adult and adolescent patients aged 12 years and older.
This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.
