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Patients in the UK will soon be able to buy the Wegovy weight-loss pill, the medicines regulator announced on Thursday.
It is the first GLP-1 receptor agonist tablet for weight-loss to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA), making the UK the third country to authorise the pills, behind the US and the United Arab Emirates.
Before now, UK patients using the drug have had to use the injectable version.
Emil Kongshøj Larsen, the executive vice-president for international operations at Novo Nordisk, the Danish multinational which makes the drug, said: “This is a landmark approval, making the UK the first country in Europe to approve Wegovy pill. We hope this approval supports increasing access to obesity care in the UK.”
The pills, which contain semaglutide, are now approved for adults who are obese (BMI of 30 or above) or overweight (BMI of 27-30) and have at least one weight-related health condition.
Clinical trials showed that those on the highest dose lost 14-17% of their body weight after 64 weeks.
Until Wegovy tablets are approved by the National Institute for Health and Care Excellence (Nice), they will not be available on the NHS and eligible patients will have to get a private prescription.
Prices have not yet been agreed, but patients will hope they are cheaper than injections. A private prescription for Wegovy injections typically costs £90-£300 a month, depending on the dose and length of prescription.
New patients will start on 1.5mg, with doses increasing to 4mg, 9mg and 25mg, with at least one month at each level. Those already treated privately with weekly 2.4mg Wegovy injections can swap straight to 25mg tablets once daily, if suitable, the MHRA said.
As with the injectable form, Wegovy pills have to be taken carefully. Patients need to take them whole with a sip of water on an empty stomach after fasting for at least eight hours, then avoid food or drink for at least 30 minutes.
The most common side effects of Wegovy pills are gastrointestinal disorders including nausea, diarrhoea, constipation and vomiting. The MHRA said anyone experiencing a side effects should talk to their doctor, pharmacist or nurse and report it directly to the yellow card scheme.
Prof Victoria Tzortziou Brown, president of the Royal College of GPs, said she looked forward to seeing what Nice says about the pills’ potential safe and appropriate use in general practice.
“Weight-loss medication can potentially benefit many patients, and being able to take it in tablet form would certainly be easier than having to inject it,” she said.
“It remains essential, though, that this medication is not seen as a magic solution for weight loss as it does come with potential side effects and won’t be appropriate for everyone.
“As such, it’s important that weight-loss medication is used as part of a broader approach to healthy weight management, including access to appropriate nutrition, physical activity and behavioural support.”
Naveed Sattar, a professor of cardiometabolic medicine at the University of Glasgow, said: “Expanding the range of effective treatments is important in helping people sustainably reduce caloric intakes within an increasingly obesogenic environment.
“With obesity rates in the UK now at very high levels, and associated with substantial multimorbidity, additional treatment options for sustained weight loss are greatly needed.”
Jason Murphy, the head of pharmacy at Chemist4U, said the announcement was a “major step forward” in treating obesity, increasing access and enabling “millions more people” to get treatment.
“For those uncomfortable injecting themselves or that find a daily pill more compatible with their life, today’s announcement could be life-changing,” he said.
“With an estimated 2.5 million people already using weight-loss injections in the UK, we should expect demand for weight-loss pills to be incredibly high and be a major foundation for tackling the obesity crisis.”
Katharine Jenner, executive director of the Obesity Health Alliance, said on Thursday: “An oral Wegovy pill could help widen access to effective treatment, especially if it is cheaper and easier for patients to use. But we must be clear thatweight-loss drugs are not a replacement for prevention.
“No medicine can fix a food system that leaves too many families surrounded by cheap, heavily marketed, less healthy food.
“That is why 65 health organisations and experts have today written to the chancellor urging the government to protect, not weaken, evidence-based policies to improve the nation’s diet. Treatment and prevention must go hand in hand.”
