The European Medicines Agency (EMA) has endorsed an extension to the marketing authorisation of Wegovy (semaglutide) in the EU for weight management. The extension enables the use of tablets, making them the first glucagon-like peptide (GLP-1) receptor agonist for weight management developed for oral use.
The tablets offer a more convenient approach for patients compared to injections and, as with the injections, are intended to be used for people who are overweight or obese, or for those who have at least one weight-related comorbidity like cardiovascular disease, type 2 diabetes or obstructive sleep apnoea. Wegovy tablets are intended for use alongside changes in diet and physical activity and are to be taken once daily on an empty stomach.
The extension covers four new strengths: 1.5 mg, 4 mg, 9 mg and 25 mg for oral use. The findings of a Phase 3 clinical trial, conducted with 307 participants, showed the efficacy of the tablet, with significant variation between results from patients taking Wegovy compared to those on placebo. The safety profile of daily intake of Wegovy tablets was similar to Wegovy injections, as well as its side effects, which mainly included gastrointestinal symptoms and nausea occurring at the start of the treatment. The only notable restriction relates to age: unlike the injections, which are appropriate for those above the age of 12, the tablets will only be available on prescription to adults. It is also worth noting that Wegovy remains under additional monitoring.
The recommendation adopted by the Committee for Medicinal Products for Human Use (CHMP) will be sent to the European Commission for a decision on the extension. Taking into consideration the potential use of the medicine and the national health systems of individual countries, discussions about price and reimbursement will take place once the extension has been granted. Novo Nordisk, the marketing authorisation holder for Wegovy, has indicated that it plans to launch the tablets in select EU markets in the second half of 2026.
