The European Medicines Agency has recommended extending the marketing authorisation for Wegovy (semaglutide) to include an oral tablet formulation for weight management, making it the first glucagon-like peptide-1 (GLP-1) receptor agonist developed for oral use in this indication.

Wegovy tablets are intended for use alongside diet and physical activity in adults with obesity or in those who are overweight with at least one weight-related comorbidity.

Oral Dosing Regimen

The tablets are taken once daily on an empty stomach after at least 8 hours of fasting. Patients should wait 30 minutes before eating, drinking, or taking other medications. While Wegovy subcutaneous injections are authorised for patients from the age of 12, the oral formulation is intended for adults only.

The oral tablet may offer a more convenient alternative for patients who prefer not to use weekly injections.

Clinical Evidence

The phase 3 trial enrolled 307 adults with obesity or who were overweight with at least one comorbidity. Participants received either Wegovy or placebo alongside a reduced-calorie diet and increased physical activity for 64 weeks.

Those taking Wegovy tablets lost an average of 13.61% of their body weight, compared with 2.18% in the placebo group. Additionally, 76.3% of participants in the Wegovy group lost at least 5% of their body weight versus 30.5% on placebo.

Safety Profile

The most common side effects were gastrointestinal disorders including nausea, diarrhoea, constipation, abdominal pain, dyspepsia, and vomiting. These occurred mainly at the start of treatment. The overall safety profile of daily oral Wegovy was similar to that of the weekly injectable formulation.

Next Steps

The opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) has been sent to the European Commission for a final decision on the extension of the EU marketing authorisation. Once granted, decisions on pricing and reimbursement will be made at the level of each Member State.

Source: EMA News