The MHRA has approved a new, stronger dose of weight loss jab Wegovy – and it could help users lose over a fifth of their bodyweight.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the 7.2 mg dose of semaglutide can now be given to patients as a maintenance dose, helping them keep off, or lose more, weight.
The once-a-week injection is already prescribed on the NHS at a maximum dose of 2.4mg. The stronger dose will need to pass a NICE review to ensure cost effectiveness before getting the final go ahead by NHS bosses before it is given to eligible patients.
The decision comes after the STEP UP clinical trial, which showed that the 7.2mg dose delivered on average up to 20.7 per cent weight loss when used in conjunction with healthy diet and regular exercise.
Around a third of the study participants – who all had a BMI over 30, placing them in the obese category – achieved a weight loss of 25 per cent or more after 72 weeks, compared with taking a placebo.
Common side effects which caused some people to stop treatment were digestive issues like nausea or stomach upset, and mostly occurred when the dose was being increased.
At the moment, the higher dose is given as three separate injections, but drugs manufacturer Novo Nordisk has applied for approval of a single injection that delivers the full dose at once, which is expected to be available later this year.
Clinical data from the STEP UP trial shows that the higher 7.2 mg once weekly dose could be used to achieve greater weight loss in people who have plateaued on the 2.4 mg maintenance dose for at least four weeks.
‘This approval represents another important step in Novo Nordisk supporting people living with obesity to achieve meaningful and significant weight loss,’ said Sebnem Avsar Tuna, General Manager, Novo Nordisk UK.
‘The addition of a new dose of semaglutide provides healthcare professionals with greater flexibility to tailor treatment for people living with obesity, supporting evidence-based approaches to improve health outcomes.’
Previously, two major international studies found that upping the amount to 7.2mg – three times higher than the currently approved level – leads to significantly greater weight loss while remaining safe.
The ‘mega dose’ could provide a new option for people who have not lost enough weight on standard treatment, including those with type 2 diabetes, suggest the researchers.
However Professor Alex Miras, an obesity expert at Imperial College London, previously told the Daily Mail that he was taking a cautious attitude towards the super-strength dose.
‘Tripling the dose only gives a marginal extra benefit, but the dose increase is massive,’ he said.
‘Going from 2.4mg to 7.2mg is a very big jump. I’m concerned many patients won’t tolerate such a high dose. In clinical practice people already struggle at 2.4mg.
‘Even if 7.2mg is approved, I suspect uptake will be low because of cost and side-effects – the top dose is already expensive.’
Semaglutide is part of a new class of medicines known as GLP-1 receptor agonists, which mimic a gut hormone to regulate appetite and blood sugar.
The drug, sold as Ozempic for diabetes and as Wegovy for weight management, has transformed obesity treatment, driving high demand and sparking debate over access.
In the UK, fewer than 200,000 people are thought to be accessing weight-loss jabs through the NHS, but over 1.4 million are estimated to be using them privately, according to the health think-tank the King’s Fund.
