Patients in the UK are expected to soon have access to three times the dose of weight loss injections after the medicines regulatory authority gave the green light for their use.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the 7.2mg dose of semaglutide can now be used as a maintenance dose, with the aim of maintaining or further increasing weight loss. Wegovy is currently prescribed by the NHS at a maximum dose of 2.4mg once a week.
However, before the stronger dose is actually made available to NHS patients, it must undergo an assessment by the National Institute for Health and Care Excellence (NICE) to determine whether it is cost-effective. Only then can final approval be given by NHS leaders.
The decision is based on the results of the STEP UP clinical study, according to which the 7.2 mg dose of semaglutide led to an average of up to 20.7 percent weight loss, when used together with a healthy diet and regular physical activity.
About a third of the study participants — all with a body mass index (BMI) over 30, i.e. in the obese category — managed to lose 25 percent or more of their body weight after 72 weeks, compared to those who took a placebo.
The most common side effects, which led some patients to discontinue treatment, were gastrointestinal disorders such as nausea and stomach upset. These occurred mainly during the dose-titration phase.
Currently, the 7.2 mg dose is administered in three separate injections. The drug's manufacturer, Novo Nordisk, has applied for approval of a single injection that delivers the entire dose at once, which is expected to be available later this year.
Clinical data from the STEP UP study indicate that the higher weekly dose may be beneficial for patients who have “frozen” in weight loss after using the 2.4 mg dose for at least four weeks.
“This approval represents another important step in Novo Nordisk’s support for people living with obesity to achieve meaningful and sustainable weight loss,” said Sebnem Avsar Tuna, managing director of Novo Nordisk in the UK.
Previous international studies have shown that increasing the dose to 7.2 mg — three times the current approved level — results in significantly greater weight loss, while maintaining the safety profile.
According to researchers, this "mega-dose" could offer a new alternative for patients who have not achieved sufficient results with standard treatment, including people with type 2 diabetes.
However, not all experts are enthusiastic. Professor Alex Miras, an obesity specialist at Imperial College London, has previously expressed a cautious approach to this high dose.
"Tripling the dose only provides a relatively modest additional benefit, while increasing the dose is very large," he stated, adding that many patients already have difficulty tolerating the 2.4 mg dose.
According to him, even if the 7.2 mg dose is fully approved, its use may remain limited due to high cost and side effects.
Semaglutide belongs to a new class of drugs known as GLP-1 receptor agonists, which mimic a gut hormone to regulate appetite and blood sugar levels. Sold as Ozempic for diabetes and as Wegovy for weight management, the drug has revolutionized obesity treatment and has sparked high demand as well as debate over access.
In the UK, fewer than 200 people are thought to receive these injections through the NHS, while over 1.4 million use them privately, according to data from the health think-tank King's Fund. /GazetaExpress/
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