European Commission authorizes Wegovy

The European Commission authorized Wegovy, the weight-management version of semaglutide, for use across the European Union on January 6, 2022 ^[1]. The decision followed the European Medicines Agency's review and made the drug available by prescription in all EU member states ^[1].

As described by the EMA, Wegovy is used together with diet and physical activity to help people lose weight and keep it off ^[1]. The authorization covers adults with a BMI of 30 kg/m² or greater, and adults with a BMI of at least 27 but under 30 who also have a weight-related health problem such as diabetes, high blood pressure, abnormal blood fats, obstructive sleep apnea, or a history of heart attack, stroke or blood vessel problems ^[1].

What the trials showed

The EMA's summary lays out the evidence behind the decision. In the first main study of 1,961 adults, people on Wegovy lost an average of 15% of their body weight after 68 weeks, compared with 2% for those on placebo; 84% of the Wegovy group lost at least 5% of their weight versus 31% on placebo ^[1].

A second study of 611 people, all of whom also received weight-loss counseling, found an average 16% loss after 68 weeks versus 6% with placebo, with about 85% reaching at least 5% loss compared with 48% on placebo ^[1].

A third study of 902 people tested what happens when treatment stops. Everyone took Wegovy for 20 weeks; some were then switched to placebo. Over the next 48 weeks, those who stayed on Wegovy lost a further 8% of their weight, while those switched to placebo regained 7% — evidence, the EMA said, that people need to keep taking the drug to avoid regaining weight ^[1].

Results were smaller in people with type 2 diabetes. In a fourth study of 1,210 adults with type 2 diabetes and a BMI of at least 27, average weight loss was 10% at 68 weeks versus 3% with placebo, and 67% lost at least 5% of their weight versus 30% on placebo ^[1].

The most common side effects listed — those that may affect more than 1 in 10 people — are headache, nausea, vomiting, diarrhea, constipation and abdominal pain ^[1]. To reduce gut side effects, the dose is increased gradually over 16 weeks ^[1].

The label has grown since 2022

The EMA's current product page, which has been updated since the original authorization, now describes uses beyond the adult injection. It covers adolescents from age 12 whose BMI is at or above the 95th percentile for their age and gender and who weigh more than 60 kg ^[1]. In a study of about 200 adolescents aged 12 to under 18, BMI dropped an average of 16% after 68 weeks versus an average increase of less than 1% on placebo, with roughly 73% losing at least 5% of their weight compared with about 18% on placebo ^[1].

The page also describes an oral form: tablets taken once daily on an empty stomach after at least 8 hours of fasting, with a 30-minute wait before eating, drinking or taking other medicines ^[1]. In a 307-person study, adults taking Wegovy tablets for 64 weeks lost about 14% of their weight versus about 2% on placebo, with roughly 76% losing at least 5% versus about 31% ^[1]. The tablets are for adults only and have not been studied in adolescents ^[1]. The exact dates when these uses were added to the EU label are not stated in the source.

Why it matters for patients

For US readers, an EU authorization does not change what is available at an American pharmacy or what insurance covers. But it matters in two practical ways.

First, it means regulators on two continents reviewed largely the same trial package and reached similar conclusions about semaglutide for weight management, including the eligibility thresholds of BMI 30, or BMI 27 with a weight-related condition ^[1].

Second, the withdrawal study is the kind of detail that shapes real-world expectations: the EMA explicitly framed Wegovy as a treatment people need to continue, citing the 7% regain seen after switching to placebo ^[1]. The EMA also noted that treatment should be stopped in adolescents who do not lose at least 5% of their weight within 12 weeks on the maximum dose, or the maximum dose they can tolerate ^[1].

What the source does not address is pricing, national reimbursement decisions in individual EU countries, or supply — all of which are decided separately from the EU-wide authorization.