Patients managing their weight with GLP-1 drugs may soon have an option that does not involve a needle. The European Medicines Agency has recommended an oral tablet formulation of Wegovy (semaglutide) for weight management, the first glucagon-like peptide-1 receptor agonist developed for oral use in this indication.

The tablets are taken once daily on an empty stomach after at least eight hours of fasting, with patients waiting 30 minutes before eating, drinking, or taking other medications. The oral formulation is intended for adults only, while the injectable version remains authorized from age 12.

The recommendation follows a phase 3 trial of 307 adults with obesity or overweight who also had at least one weight-related comorbidity. Participants received either Wegovy or placebo alongside a reduced-calorie diet and increased physical activity for 64 weeks. Those on Wegovy tablets lost an average of 13.61% of their body weight, compared with 2.18% in the placebo group. More than 76% of Wegovy users lost at least 5% of their body weight, versus 30.5% on placebo.

Side effects were mainly gastrointestinal — nausea, diarrhea, constipation, abdominal pain, and vomiting — occurring mostly at the start of treatment. The safety profile matched that of the weekly injectable formulation.

The opinion from EMA’s Committee for Medicinal Products for Human Use now goes to the European Commission for a final decision. Pricing and reimbursement will be decided at the level of each member state.

Source: EMA News