Semaglutide has become the “first weight loss drug approved in the UK as a preventative treatment for those with established cardiovascular disease”, the Medicines and Healthcare products Regulatory Agency (MHRA) announced.
The MHRA yesterday (July 23) granted authorisation for a new indication for the drug to Novo Nordisk, the company that manufactures GLP –1 receptor agonist semaglutide under the brand name Wegovy, it revealed.
Now the weight loss injections can also be used “to reduce the risk of overweight and obese adults suffering serious heart problems or strokes”, it said.
Read more: Four ‘pending’ prosecutions in NI over illicit weight loss drugs
It added that the drug can be used 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”.
The approval follows “a multi-national, multi-centre, placebo-controlled double-blind trial”, which demonstrated that “up to five years” of Wegovy 2.4 mg once weekly subcutaneous injections “lowers the incidence of major adverse cardiovascular events”, it said.
Read more: Wegovy: 'I really hope the NHS crack down on this. I am forever traumatised by what happened'
“This medicine…was already approved for use in the treatment of obesity and for weight management, to be used alongside diet, physical activity and behavioural support,” the MHRA added.
“The most common side effects of the medicine are gastrointestinal disorders including nausea, diarrhoea, constipation and vomiting,” it said.
“An important step forward”
Commenting on the approval, MHRA deputy director of innovative medicines Shirley Hopper said that the regulator’s “key priority is enabling access to high quality, safe and effective medical products”.
“This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity,” she said, adding that “as with all medicines, [the MHRA] will keep its safety under close review”.
Read more: 'I'm terrified someone is going to die' - Wes Streeting demands tighter regs around Wegovy
British Heart Foundation chief scientific and medical officer Professor Bryan Williams said that “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,” he added.
He stressed that it is “important that people using the drug to lose weight and improve their health are given the support they need” including via “appropriate training and healthcare workforce development, along with policies” to create a healthier environment.
Wegovy worries
Earlier this month, Northern Ireland health minister Mike Nesbitt revealed that the country has successfully prosecuted one person, with four more prosecutions “pending”, over the unlawful supply of counterfeit or unlicensed weight loss drugs.
And last month, C+D exclusively revealed that a “young girl” had to be treated in A&E after presenting with life threatening symptoms after taking weight loss drug Wegovy obtained through Boots Online Doctor.
Read more: Wegovy online prescription warning - pharmacists threatened by GPhC action
At the time, the body representing acute doctors raised the alarm with the medicines watchdog about the regulation of “life threatening” weight loss drugs obtained online.
And now-health secretary Wes Streeting said that a Labour government would look “very carefully” at changing weight loss drug regulation.
