The Medicines and Healthcare products Regulatory Agency (MHRA)
has today (3 July 2026) approved a semaglutide injection (Wegovy)
to treat metabolic-associated steatohepatitis (MASH) in adults
with moderate-to-advanced liver fibrosis (scar tissue in the
liver).
Semaglutide has existing authorisations for weight management in
adults and adolescents and for the reduction of cardiovascular
events in adults.
MASH develops when excess fat in the liver causes inflammation
and scarring. You are more likely to develop MASH if you have
obesity, type 2 diabetes, or high blood lipid levels.
Beach, Executive Director of
Healthcare Quality and Access at the MHRA, said:
The available evidence indicates that semaglutide is a safe and
effective treatment option for patients with MASH. As with all
GLP-1 receptor agonists, this is a prescription-only medication
and should only be taken in consultation with a doctor.
The starting dose of 0.25 mg semaglutide once weekly is increased
to doses of 0.5mg, 1mg, 1.7mg, with four weeks on each dose, up
to the maintenance dose of 2.4 mg once weekly. For patients with
obesity (a BMI over 30), the dose can be increased to 7.2 mg once
weekly after a minimum of 4 weeks on the 2.4 mg dose.
Semaglutide has been approved to treat MASH on the condition that
further results from an ongoing study in adults with MASH and
moderate to advanced liver scarring will be submitted. The
product has a conditional marketing authorisation because further
confirmatory evidence is required of its efficacy and safety as a
treatment for MASH before a full marketing authorisation can be
issued.
The MHRA will review new information on this medicine at least
every year and the Summary of Product Characteristics will be
updated, as necessary.
Patients with MASH are not currently able to get semaglutide to
treat this condition on the NHS. This is subject to a decision
from the National Institute for Health and Care Excellence (NICE)
which is currently
appraising its clinical and cost effectiveness as a treatment
option for MASH.
Semaglutide is a GLP-1 receptor agonist prescribed in combination
with diet and exercise. It works by mimicking the action of a
naturally occurring hormone, glucagon-like peptide (GLP-1), which
is released by the body after eating, helping people feel fuller
for longer and decreasing food cravings.
As with any medicine, the MHRA keeps the safety and effectiveness
of semaglutide under close review.
The most common side effects of the medicine are gastrointestinal
disorders including nausea, diarrhoea, constipation and vomiting.
Anyone who suspects they are having a side effect from this
medicine is encouraged to talk to their doctor, pharmacist or
nurse and report it directly to the Yellow Card scheme, either
through the website
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors:
- Authorisation for this new indication for semaglutide
(Wegovy) was granted on 3 July 2026 to Novo Nordisk.
- 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.
