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Health officials in the UK have given the green light for a weight-loss jab to be used to prevent heart attacks and strokes in overweight people.
Semaglutide, sold under the brand name Wegovy, has already been approved for weight management in people with obesity.
Now, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug for a new purpose – to help reduce the risk of heart problems in people who are overweight or obese.
It is the first weight-loss drug approved in the UK as a preventative treatment for those with “established cardiovascular disease”, the MHRA said.
This means that the drug can be prescribed to people with a body mass index (BMI) score of 27 or over who have already been diagnosed with cardiovascular disease – a term which describes conditions relating to the heart of blood vessels.
The medicine makes people feel fuller and less hungry. It is prescribed for the treatment of obesity for weight management alongside diet, physical activity and behavioural support.
The approval comes after a new study found that the drug – taken as an injection once a week for up to five years – can lower a person’s risk of major cardiovascular events such as heart attack and stroke.
Some 17,600 people took part in the trial and were either prescribed Wegovy or a dummy drug, also known as a placebo.
Researchers found that Wegovy, which is manufactured by Novo Nordisk, significantly reduced the risk of major adverse cardiovascular events by 20%.
The MHRA approval is a step towards the drug being used in the NHS. Before it is used on a widespread basis in the health service it still needs to be appraised by the National Institute for Health and Care Excellence (Nice).
Shirley Hopper, MHRA’s deputy director of innovative medicines, said: “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.”
Commenting on the announcement, 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.”
Semaglutide is known as a GLP-1 receptor agonist and works by mimicking the GLP-1 hormone, which is involved in regulating blood sugar levels. It enhances insulin secretion in response to food, reduces the amount of glucose, or sugar, produced by the liver and slows down how quickly food is digested.
Earlier this year, Novo Nordisk warned over supply constraints as it said it was seeing strong demand for its obesity treatments around the world.
In a statement responding to the new MHRA approval, the Danish company said: “This additional indication for Wegovy provides a treatment option to reduce cardiovascular risk in people with established cardiovascular disease living with overweight or obesity in Great Britain.
“Despite therapeutic advances in cardiovascular disease management, a significant ongoing need persists for treatment options that can address cardiovascular diseases in people living with overweight or obesity.
“Novo Nordisk intends to continue its discussions with health authorities to provide accessibility for those with the highest ongoing need.
“Novo Nordisk continues to provide a protected supply of Wegovy to the NHS with supply readily available. Non-NHS supply will continue to remain constrained and limited for the foreseeable future.”
Professor Sir Stephen Powis, national medical director for NHS England, said: “If this treatment is recommended by the National Institute for Health and Care Excellence, then the NHS in England can use Wegovy to help reduce cardiovascular risks for high-risk patients, potentially preventing heart attacks and strokes, and giving more people the chance of a healthier future.
“Weight loss drugs can be key part of our arsenal to help tackle obesity and manage associated risks but, as global supply issues continue to affect these drugs, it is important that treatments are used correctly, in line with licensing, to ensure that patients with type 2 diabetes can receive the medicines they need.”
