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.
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 to editors
-
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.
-
More information can be found in the Summary of Product
Characteristics and Patient Information Leaflets which will
be published on the MHRA Products website within 7 days of
approval.
