The UK’s medicines regulator has approved the use of semaglutide (Wegovy) for cardiovascular prevention in obese and overweight patients with established CVD.
The Medicines and Healthcare products Regulatory Agency (MHRA) granted the authorisation on Tuesday this week, making it the first weight loss drug to be prescribed as a preventative treatment for cardiovascular events.
The drug, supplied by Novo Nordisk, is already approved and used as a treatment for obesity, alongside lifestyle changes and support.
It can now be used to reduce the risk of overweight and obese adults suffering events such as cardiovascular death, non-fatal heart attacks and non-fatal strokes, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2.
The MHRA has granted this authorisation based on new data from a clinical study which found that semaglutide reduces the incidence of major adverse cardiovascular events (MACE) by 20% when compared with a placebo.
There were over 17,600 participants in the multi-national, double-blind trial who were randomly assigned either Wegovy or a placebo.
Novo Nordisk first revealed headline figures from this study a year ago, with full results since published in the New England Journal of Medicine.
At the time, the company said it expected to file for regulatory approvals for a label indication expansion of semaglutide 2.4mg during 2023.
MHRA deputy director of innovative medicines Shirley Hopper said that they will keep the safety of Wegovy ‘under close review’.
She 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.’
Professor John Wilding, professor in the department of cardiovascular medicine at the University of Liverpool, said the approval is ‘good news’ based on evidence from the trial.
He continued: ‘Semaglutide is already approved for treatment of obesity, but despite a favourable NICE appraisal since 2023, many people living with obesity in England and Wales are still unable to access this treatment due to funding restrictions and limited availability of NHS services for the treatment of obesity.
‘It is hoped that this new widened indication will help funders of services to understand the benefits of treatment for people living with obesity, and provide appropriate support for clinical services to provide treatment.’
Dr Martin White, associate professor in metabolic medicine at the University of Surrey, said that data from the trial also showed that there was ‘no difference in cardiovascular outcomes in those who did or did not achieve 5% weight loss’ after 20 weeks of semaglutide.
‘This hints that weight loss per se may not be a crucial factor, but any benefit may instead relate to benefits on blood pressure, glucose and body inflammation,’ he suggested.
Semaglutide, which is a GLP-1 receptor agonist, was launched on the NHS as a weight-loss drug in September.
The drug is available via specialist NHS weight management services for people who meet NICE criteria, or privately through a registered healthcare professional, but has been in short supply due to global demand.
A recent study indicated that weight loss in patients on semaglutide can be sustained for up to four years.
Unlike NICE recommendations for semaglutide, which limited use to tier 3 specialist weight management services, NICE has said tirzepatide – another weight loss drug – can be prescribed by GPs.
