Wegovy (semaglutide; Novo Nordisk) has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use for use in adolescents aged 12 years and above.
On 30 March 2023, the Committee adopted a positive opinion recommending a change to the terms of the marketing authorisation for the product to include the new age group.
In Europe, the drug was initially indicated for adults with a body mass index (BMI) of 30kg/m2 or more, or those with a BMI of ≥27kg/m2 to <30 kg/m2, who have at least one weight-related comorbidity, such as hypertension.
However, the proposed change means the drug can now be prescribed for weight management in adolescents aged 12 years and above with obesity and body weight above 60kg.
The Committee also advised that treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on a 2.4mg or maximum tolerated dose.
Wegovy is a glucagon-like peptide (GLP-1) receptor agonist, which is injected once per week and indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance.
In March 2023, the National Institute for Health and Clinical Excellence approved its use in the UK for adults with obesity with at least one risk factor, through specialist NHS services.
The Pharmaceutical Journal approached the Medicines and Healthcare products Regulatory Agency to ask if it was planning to expand the indication for Wegovy in the UK. It responded that, owing to commercial confidentiality, it was unable to confirm the status of any potential marketing authorisation applications or give timelines.
A spokesperson for Novo Nordisk also said the company were unable to comment on enquiries related to label extensions of Wegovy in the UK “at this time”.
Alex Miras, professor of endocrinology at Ulster University in Belfast, Northern Ireland, said he would support the use of the medication in adolescents, provided they were monitored by a multidisciplinary team.
He added: “There is a group of teenagers that are suffering from the disease of obesity with regards to their physical and mental health and social functioning, and, like adults, need treatment in order to reduce the symptoms and complications of the disease. The evidence for the safety and efficacy of Wegovy in this group of teenagers comes from randomised controlled trials and is very promising.”
Philip Newland-Jones, consultant pharmacist in diabetes at University Hospital Southampton NHS Foundation Trust, also said he would welcome the licensing of Wegovy for paediatric patients.
“Around the country, there are regional clinics for young people under 18 that are run by endocrinology departments,” he said. “Southampton, where I work, has one of these clinics, and we have approximately 40 children on unlicensed semaglutide (1mg), currently as part of an NHS England-approved, commissioned service.
“[But] because there’s no medicines available, we use the diabetes dose — the 1mg semaglutide once a week — in this group already, alongside a very specialist service with psychologists, specialist dietitians [and] specialist endocrinologists,
“So, having a dose that’s actually got evidence for weight loss at higher dose … is only going to be a good thing for this particular population.”
However, Newland-Jones said that one of the issues with the service, that would need to be considered should the use of Wegovy be expanded to include adolescents in the UK, is that there is nowhere for these patients to go once they reach adulthood.
“It’s basically a huge gap between the commissioning arrangements because they’ve agreed to fund this medicine, off licence, in particular groups but when they reach 18 there’s no agreement that the adult endocrinology service can prescribe this medicine ongoing, and the only way that you can prescribe semaglutide for weight loss is in a tier three weight loss service, and it’s only for a maximum of two years … in children, we don’t use it for just the two years, they use it and if it works, we continue.”
On 3 April 2023, The Pharmaceutical Journal revealed that experts were concerned about the level of support that will be given to patients buying Wegovy privately online and from community pharmacies.