A post-approval clinical study showed that Wegovy significantly reduced the risk of major adverse cardiovascular events by 20% compared to a placebo
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of semaglutide (Wegovy), authorising its use to reduce the risk of serious heart problems and strokes in adults who are obese or overweight.
Semaglutide, a GLP-1 receptor agonist, was previously approved for use in the treatment of obesity and weight management, to be used alongside diet, physical activity and behavioural support.
The latest approval establishes it as 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.
Novo Nordisk, the manufacturer of Wegovy, received this authorisation on 23 July following compelling evidence from a recent post-approval clinical study involving over 17,600 participants.
The study demonstrated that Wegovy, administered at a dose of 2.4 mg once weekly via subcutaneous injection for up to five years, significantly lowers the incidence of major adverse cardiovascular events (MACE) by 20 per cent compared to a placebo.
Specifically, 6.5 per cent of participants receiving Wegovy experienced cardiovascular events such as cardiovascular death, heart attack and stroke, compared to 8 per cent of those on the placebo.
Shirley Hopper, MHRA Deputy Director of Innovative Medicines, confirmed that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met.
Hopper described this new treatment option as an “important step forward in tackling the serious health consequences of obesity.”
Professor Bryan Williams, Chief Scientific and Medical Officer at the British Heart Foundation, highlighted that several recent studies have shown semaglutide’s effectiveness in improving the quality of life for those with cardiovascular disease, including by lowering the risk of serious cardiac events.
Semaglutide works by mimicking the action of the GLP-1 hormone, which is involved in regulating blood sugar levels. It binds to GLP-1 receptors on pancreatic cells, enhancing insulin secretion in response to meals, reducing glucagon release, and slowing the gastric emptying process, thereby promoting weight loss.
The treatment is taken as a solution for injection in a pre-filled pen.
The MHRA noted the most common side effects of the medicine are gastrointestinal disorders including nausea, diarrhoea, constipation and vomiting.
Professor Williams stated that that nearly two-thirds of adults in England are living with excess weight or obesity.
He cautioned that those with existing cardiovascular disease have a very high risk of developing a severe event such as a heart attack or stroke.
Cardiovascular disease (CVD) refers to a range of conditions that affect the heart and blood vessels.
It is commonly linked to the build-up of fatty deposits inside the arteries (atherosclerosis) and an increased risk of blood clots.
In the UK, CVD is a leading cause of death and disability, but it can often be prevented through a healthy lifestyle.
