UK drug regulators have approved semaglutide, the main ingredient in Ozempic and Wegovy, for use as a preventative drug against heart attacks and strokes.
The move comes after scientists hailed the results of a trial earlier this year that showed patients taking the drugs cut their chances of suffering from such health problems by up to a fifth and called for their wider use.
Announcing the move, the Medicines and Healthcare products Regulatory Agency (MHRA) said weekly injections should now be offered to overweight and obese adults with cardiovascular disease as a “preventative treatment”.
It could open the door for millions more Britons to receive fat-blasting vaccines.
The expansion of the conditions for which semaglutide can be prescribed applies only to Wegovy, the formulation of the drug for patients who want to lose weight, rather than Ozempic, which remains specific to diabetes.
UK drug regulators based their decision on the largest study yet of Ozempic and Wegovy, which found their key ingredient was a “game changer” for heart patients, including those who did not lose weight.
It is the first weight-loss drug prescribed to prevent cardiovascular events such as heart attacks and strokes.
Cardiovascular disease is responsible for around a quarter of all deaths in the UK, equivalent to 170,000 deaths a year or 480 every day.
The MHRA said conditions for receiving Wegovy in these circumstances include having a body mass index of 27 or more, a reading that means someone is overweight, and established cardiovascular disease.
Currently, people in the UK can only get Wegovy through the NHS if they have at least a BMI of 30 and a health condition related to their weight, such as high blood pressure.
The MHRA’s decision does not mean that the NHS will prescribe Wegovy on this new basis immediately.
A separate body, the National Institute for Health and Care Excellence (NICE), is to assess whether using Wegovy is value for money for taxpayers’ money.
NICE told MailOnline that it hopes to publish the results of that assessment next summer.
MHRA officials based their decision on a clinical study of more than 17,000 people that found those who received the weekly vaccine for up to five years had reduced their risk of major adverse cardiovascular events by 20 percent.
Shirley Hopper, deputy director of innovative medicines at the MHRA, said: ‘We are confident that the appropriate regulatory standards of safety, quality and efficacy have been met for the approval of this medicine.
‘This treatment option that prevents heart disease and stroke is an important step forward in addressing the serious health consequences of obesity.
“As with all medicines, we will closely monitor its safety.”
Professor Bryan Williams, scientific and medical director at the British Heart Foundation, said: ‘Almost two-thirds of adults in England are living with excess weight or obesity.
‘Those who also have established cardiovascular disease live at very high risk that a serious event such as a heart attack or stroke can occur.
‘Several recent studies have shown us that semaglutide is an effective tool that can improve the quality of life of people with cardiovascular diseases, even reducing the risk of serious cardiac events.
Wegovy and Ozempic work by stimulating the body to produce a hormone called GLP-1 that is naturally released from the intestines after meals.
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‘It is important that people who use the drug to lose weight and improve their health receive the support they need from health professionals to maintain these improvements in the long term.
“This involves appropriate training and development of the healthcare workforce, along with policies to create a broader environment that helps everyone stay as healthy as possible. Together, this can help save lives from the devastating impact of heart attacks and strokes.”
Ozempic and Wegovy are injections that mimic hormones and trick the body into feeling full, helping people lose weight.
Losing weight already helps reduce the risk of heart attacks and strokes, however, the clinically observed risk reduction was also evident among patients who did not lose weight.
This suggests that the drugs target an underlying biological mechanism that reduces the risk of such events.
Doctors believe this could be due to mechanisms such as improvements in blood sugar, blood pressure or inflammation, as well as direct effects on the heart muscle and blood vessels.
While semaglutide-based drugs have been linked to a number of benefits, they, like any drug, have side effects that vary in severity and frequency.
The most common are gastrointestinal disorders, such as nausea, diarrhea, constipation and vomiting.
But other, stranger symptoms, such as hair loss, have also been reported in some patients.
British ministers had previously planned to distribute the drug to millions of overweight Britons to cut both the country’s bloated benefits bill from sick Britons taking time off work and the rising cost to the NHS of treating excess fat.
Although hormone-mimicking injections are designed to help overweight patients become healthier, there has also been growing concern about the number of normal-weight and underweight patients taking them for cosmetic reasons.
Some have even needed emergency room care after receiving vaccines in an attempt to get a “beach-ready” body.
Young women in particular are believed to be obtaining Wegovy through online pharmacies, which offer it for between £150 and £200 ($200-$250) a month, after providing false information about their appearance and health.
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In some cases, people who get vaccinated without a legitimate medical reason are thought to be doing so as a result of eating disorders.
Rising global demand for vaccines, even among those receiving them for cosmetic reasons, has meant that some diabetes patients are struggling to access supplies.
It has also led pharmaceutical giant Novo Nordisk, which makes Ozempic and Wegovy, to enjoy a huge boom in profits.
Earlier this year, the Danish company revealed it was making £32m a day as countries struggling with the financial toll of obesity struggle to get their hands on vaccines.
Analysis suggests combined sales of the company’s Ozempic and Wegovy brands generated £20.5bn this year.
