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The Medicines and Healthcare products Regulatory Agency approved Wegovy pills for weight management.
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Wegovy is the first GLP-1 receptor agonist tablet approved by the regulator for this indication.
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The U.K. is the third country to authorize the pill formulation, following the U.S. and the U.A.E.
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Wegovy pills contain the active ingredient semaglutide.
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The regulator approved the medication for adults with a body mass index of 30 or higher, or a body mass index between 27 and 30 with at least one weight-related health condition.
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Clinical trials showed that patients on the highest dose lost between 14 percent and 17 percent of their body weight over 64 weeks.
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The medication will not be available through the National Health Service until reviewed by the National Institute for Health and Care Excellence.
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The manufacturer has not yet submitted an application for the pill to the health technology assessment body.
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Patients must obtain a private prescription to purchase the pills.
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The prescribed starting dose is 1.5 mg taken once daily.
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Dosage increases follow a schedule to 4 mg, 9 mg, and 25 mg, with a minimum duration of one month at each level.
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Patients currently taking weekly 2.4 mg injections can transition directly to daily 25 mg tablets if deemed suitable by the regulator.
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Patients must swallow the pills whole with water after fasting for at least eight hours.
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Patients must avoid eating or drinking for 30 minutes after taking the pill.
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The tablet formulation does not require refrigeration.
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Pricing for the U.K. market has not been finalized.
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Private prescriptions for the injectable version typically cost between £90 and £300 per month.
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The manufacturer initially listed the U.S. price for the 1.5 mg starting dose at $149 per month.
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Semaglutide mimics the GLP-1 hormone to suppress appetite and slow digestion.
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Common gastrointestinal side effects include nausea, diarrhea, constipation, and vomiting.
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The regulator advises patients to consult a healthcare professional and report adverse reactions through the pharmacovigilance reporting system.
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Approximately 16 million adults in the U.K., representing one-third of the adult population, are classified as obese.
Emil Kongshøj Larsen, Executive vice-president for international operations at Novo Nordisk
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Emil Kongshøj Larsen said, "This is a landmark approval, making the U.K. the first country in Europe to approve Wegovy pill. We hope this approval supports increasing access to obesity care in the U.K."
Victoria Tzortziou Brown, President of the Royal College of General Practitioners
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Victoria Tzortziou Brown said, "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. 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, Professor of cardiometabolic medicine at the University of Glasgow
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Naveed Sattar 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 U.K. now at very high levels, and associated with substantial multimorbidity, additional treatment options for sustained weight loss are greatly needed."
Jason Murphy, Head of pharmacy at Chemist4U
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Jason Murphy said, "For those uncomfortable injecting themselves or that find a daily pill more compatible with their life, today’s announcement could be life-changing. With an estimated 2.5 million people already using weight-loss injections in the U.K., we should expect demand for weight-loss pills to be incredibly high and be a major foundation for tackling the obesity crisis."
Olivier Picard, Chair of the National Pharmacy Association
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Olivier Picard said, "Pharmacies are awaiting further guidance about when this treatment will be available for patients. We are concerned about a growing black market for counterfeit weight-loss treatments, with a tablet form of medication potentially easier for criminals to counterfeit."
Katharine Jenner, Executive director of the Obesity Health Alliance
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Katharine Jenner said, "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 that weight-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."
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