The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 23 July 2024, approved a new indication for
semaglutide (Wegovy) to reduce the risk of overweight and obese
adults suffering serious heart problems or strokes.
This medicine, a GLP-1 receptor agonist, was already approved for
use in the treatment of obesity and for weight management, to be
used alongside diet, physical activity and behavioural support.
The approval means that semaglutide is the first weight loss drug
to be prescribed to prevent cardiovascular events, such as
cardiovascular death, non-fatal heart attack and non-fatal
stroke, in people with established cardiovascular disease and a
Body Mass Index (BMI) higher or equal to 27 kg/m2.
Cardiovascular disease (CVD)
is a general term for conditions affecting the heart or blood
vessels. It is usually associated with a build-up of fatty
deposits inside the arteries (atherosclerosis) and
an increased risk of blood clots.
CVD is one of the main causes of death and disability in the UK,
but it can often be prevented by leading a healthy lifestyle.
The approval is based on new data from a post-approval clinical
study which demonstrated that semaglutide (2.4 mg once weekly by
subcutaneous injection, for up to five years) lowers the
incidence of major adverse cardiovascular events (MACE) vs
placebo.
In a multi-national, multi-centre, placebo-controlled
double-blind trial that
randomly assigned over 17,600 participants to receive either
Wegovy or a placebo, Wegovy significantly reduced the risk of
major adverse cardiovascular events by 20%, such as
cardiovascular death, heart attack and stroke, which occurred in
6.5% of participants who received Wegovy compared to 8% of
participants who received placebo.
Shirley Hopper, MHRA Deputy Director of Innovative
Medicines, said:
Our key priority is enabling access to high quality, safe
and effective medical products.
We're assured that the appropriate regulatory standards of
safety, quality and effectiveness for the approval of this
medicine have been met. This treatment option that prevents heart
disease and strokes is an important step forward in tackling the
serious health consequences of obesity.
As with all medicines, we will keep its safety under close
review.
Professor Bryan Williams, Chief Scientific and Medical
Officer at the British Heart Foundation, said:
Nearly two thirds of adults in England are living with excess
weight or obesity. Those that also have an established
cardiovascular disease live with a very high risk that a serious
event like a heart attack or stroke could happen.
Several recent studies have shown us that semaglutide is an
effective tool that can improve the quality of life for those
with cardiovascular disease, including by lowering the risk of
serious cardiac events.
It is important that people using the drug to lose weight and
improve their health are given the support they need from
healthcare professionals to maintain these improvements long into
the future. This means appropriate training and healthcare
workforce development, along with policies to create a wider
environment that supports everyone to stay as healthy as
possible. Altogether, this can help save lives from the
devastating impact of heart attacks and strokes.
The treatment is taken as a solution for injection in a
pre-filled pen.
The active ingredient, semaglutide, is a GLP-1 receptor agonist.
This mimics the action of the GLP-1 hormone, which is involved in
regulating blood sugar levels. Semaglutide binds to GLP-1
receptors on pancreatic cells, enhancing the insulin secretion in
response to meals, reducing glucagon release and slowing the
gastric emptying process. This helps to promote weight loss.
The most common side effects of the medicine are gastrointestinal
disorders including nausea, diarrhoea, constipation and vomiting.
As with any medicine, the MHRA keeps the safety and effectiveness
of semaglutide under close review. 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 23 July 2024 to Novo Nordisk.
- The authorisation was granted as part of the International
Recognition Procedure (IRP), via the reference regulator, the
Food and Drug Administration in the USA. Launched in January this
year, the IRP allows the MHRA to accelerate the assessment of new
medicines by taking into account the expertise and
decision-making of trusted regulatory partners in the
authorisation process.
- 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.
