HQ Team
July 24, 2024: The UK’s Medicines and Healthcare products Regulatory Agency has approved Novo Nordisk’s weight-loss drug to cut the risk of obesity and adults suffering from heart problems or stroke.
Semaglutide, branded as Wegovy, is a GLP-1 receptor agonist that was already approved for use in the treatment of obesity and for weight management, to be used alongside diet, physical activity and behavioural support.
In March the US Food and Drug Administration had already approved the drug for treating the same conditions.
The UK regulator’s approval was 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 when compared to placebo.
20% cut in heart risks
A trial randomly assigned more than 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 a placebo.
“We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met,” said Shirley Hopper, MHRA Deputy Director of Innovative Medicines.
“This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity.”
Healthy lifestyle
Cardiovascular disease 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.
With the UK approval, semaglutide became 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 higher or equal to 27 kg/m2.
Cardiovascular disease is one of the main causes of death and disability in the UK, but it can often be prevented by leading a healthy lifestyle.
Nearly two-thirds of adults in England were living with excess weight or obesity, said Professor Bryan Williams, Chief Scientific and Medical Officer at the British Heart Foundation.
“Those who have an established cardiovascular disease live with a very high risk that a serious event like a heart attack or stroke could happen.
Enhance insulin secretion
“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,” he said.
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 insulin secretion in response to meals, reducing glucagon release and slowing the gastric emptying process. This helps to promote weight loss.
