A new daily weight management pill has been approved in the UK, as an adjunct to a reduced calorie diet and increased physical activity, offering a first-of-its-kind alternative to injectable treatments, for adults.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Wegovy pill (semaglutide tablets), an oral glucagon-like peptide-1 (GLP-1) receptor agonist licensed for weight management in adults living with obesity or overweight with at least one weight-related condition.
The MHRA approval is based on data from the OASIS 4 phase 3 clinical trial. When evaluating the effect of treatment regardless of adherence, adults with obesity receiving semaglutide tablets 25mg achieved ~14% (13.6%) weight loss vs ~2% (2.4%) with placebo after 64 weeks, in addition to lifestyle modifications. Results showed that if all participants adhered to treatment, semaglutide 25 mg achieved weight loss of ~17% (16.6%) vs ~3% (2.7%) placebo after 64 weeks.
The study evaluated semaglutide tablets 25mg in 307 adults with obesity, or overweight with at least one weight-related condition, without diabetes. In the study, the most commonly reported side effects were gastrointestinal, including nausea, vomiting and diarrhoea, reported by 74.0% participants in the oral semaglutide group and by 42.2% in the placebo group respectively. These side effects were generally mild-to-moderate and transient. In OASIS 4, adverse events leading to treatment discontinuation occurred in ~7% (6.9%) of participants receiving oral semaglutide, which is consistent with rates observed in trials of injectable semaglutide.
“This marks an important milestone for obesity care in the UK,” said Sebnem Avsar Tuna, General Manager at Novo Nordisk UK. “For the first time, people living with obesity have access to a GLP-1 treatment in a daily pill, allowing them the choice and flexibility of oral treatment to support their long-term weight management.”
Professor Naveed Sattar, Professor of Cardiometabolic Medicine at the School of Cardiovascular & Metabolic Health at the University of Glasgow, said: “The approval of the once-daily oral form of Wegovy (semaglutide) is welcome news for people living with obesity, particularly those who would prefer not to use injections.
“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.”
“This is a landmark approval, making the UK the first country in Europe to approve Wegovy pill,” said Emil Kongshøj Larsen, Executive Vice President, International Operations at Novo Nordisk. “Around 15 million people in the UK are living with obesity, yet only a small proportion of them have access to treatment and we hope this approval supports increasing access to obesity care in the UK.
“With the introduction of this option for weight management, we have an opportunity to support many more eligible patients. Most importantly, this gives patients another option – one that may fit their lives and help them reach their health goals.”
The MHRA is the third regulatory authority to license the medicine, after the US FDA and the United Arab Emirates Drug Establishment.