British health officials have approved the use of a weight-loss injection to prevent heart attacks and strokes in overweight people.
Semaglutide, sold under the brand name Wegovy, is already approved for weight management in obese people.
Now the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug for a new purpose: reducing the risk of heart disease in people who are overweight or obese.
The MHRA said it was the first weight loss drug to be approved in the UK as a preventive treatment for people with “established cardiovascular disease”.
This means the drug can also be prescribed to people who have already been diagnosed with cardiovascular disease (a term that describes conditions related to the blood vessels of the heart) and who have a BMI (body mass index) score of 27 or above.
The drug makes you feel full and reduces hunger. It is prescribed in the treatment of obesity for weight control in conjunction with diet, physical activity, and behavioral support.
The approval came after new research found that the drug, taken as a once-weekly injection for up to five years, could lower the risk of serious cardiovascular events, including heart attack and stroke.
About 17,600 people took part in the trial and were given either Wegovy or a fake pill (also called a placebo).
Researchers found that Wegovy, manufactured by Novo Nordisk, significantly reduced the risk of serious cardiovascular events by 20%.
MHRA approval is the first step towards the drug being used in the NHS – it must be assessed by the National Institute for Health and Care Excellence (Nice) before it can be used widely in the health service.
Shirley Hopper, deputy director for innovative medicines at the MHRA, said: “We are confident that the appropriate regulatory standards of safety, quality and effectiveness required for the approval of this medicine have been met.”
“This treatment to prevent heart disease and stroke is an important step in tackling the serious health consequences of obesity.
“As with all medicines, safety will be monitored closely.”
Commenting on the announcement, Professor Brian Williams, chief scientific and medical officer at the British Heart Foundation, said: “Almost two-thirds of adults in England are living with overweight or obesity.
“People with cardiovascular disease are at a much higher risk of experiencing serious conditions such as heart attack and stroke.
“Several recent studies have shown that semaglutide is an effective tool that can improve the quality of life of people with cardiovascular disease, including reducing the risk of serious heart attacks.
“It is important that people who use this medicine to lose weight and improve their health receive the support they need from their healthcare professionals to maintain these improvements into the future.”
“This means the right training and development of our healthcare workforce, and policies that create a broader environment that supports everyone to stay as healthy as possible – all of which, taken together, will save lives from the devastating effects of heart attack and stroke.”
Semaglutide is known as a GLP-1 receptor agonist, which means it works by mimicking the GLP-1 hormone, which is involved in regulating blood sugar levels. It stimulates insulin secretion in response to food, reduces the amount of glucose (sugar) produced in the liver and slows the rate at which food is digested.
Novo Nordisk warned of supply constraints earlier this year, saying demand for its obesity drugs was growing 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 for people in the UK who are overweight or obese and have cardiovascular disease.”
“Despite therapeutic advances in the management of cardiovascular disease, there remains a significant need for treatment options that can address cardiovascular disease in overweight and obese people.
“Novo Nordisk intends to continue discussions with health authorities to provide access to those with the greatest ongoing need.”
“Novo Nordisk continues to safely supply Wegovy to the NHS and supplies are immediately available. Supplies to non-NHS will remain constrained and limited for the time being.”
Professor Stephen Powis, national medical director for NHS England, said: “If this treatment is recommended by the National Institute for Health and Care Excellence, the NHS in England will be able to use Wegovy to reduce the risk of cardiovascular disease in high-risk patients, preventing heart attacks and strokes and giving more people the chance of a healthier future.”
“Weight loss medications can be an important weapon in the fight against obesity and help manage associated risks, but as global supply issues continue to affect these medicines, it is vital that treatments are used correctly and in accordance with approval to ensure people with type 2 diabetes receive the medication they need.”
Dr Simon Cork, senior lecturer in physiology at Anglia Ruskin University, said: “The news that semaglutide has now been approved for use in people with cardiovascular disease, particularly those associated with obesity, is welcome.
“Importantly, recent studies have shown that semaglutide reduces major adverse cardiovascular events (such as heart attack and stroke) by 20%, independent of the amount of weight lost.
“This has important clinical implications because current guidelines state that patients should only continue semaglutide if they have achieved a 5% loss of body weight within six months.
“It remains to be seen whether these new approvals will maintain this requirement for patients with established cardiovascular disease.”
release date: Radio News Hub
