Overview
- The EMA's Committee for Medicinal Products for Human Use issued a positive opinion recommending that Wegovy tablets in four strengths (1.5 mg, 4 mg, 9 mg and 25 mg) be added to the product's EU marketing authorisation.
- The tablets are prescription-only, intended for adults with BMI ≥30 or BMI ≥27 to <30 with at least one weight-related comorbidity, and must be taken once daily on an empty stomach after at least eight hours of fasting with a 30-minute wait before eating or other medicines.
- A phase 3 trial of 307 adults found an average weight loss of 13.61% with daily Wegovy tablets versus 2.18% with placebo and showed 76.3% of treated patients lost at least 5% of body weight compared with 30.5% on placebo.
- The most common side effects were gastrointestinal disorders such as nausea, diarrhoea, constipation and vomiting, which mainly occurred at treatment start, and the tablets' safety profile was judged similar to weekly Wegovy injections.
- The CHMP opinion is an intermediary regulatory step that now goes to the European Commission for a final decision and, if authorised, national price and reimbursement processes will determine patient access and wider market impact.