European Commission authorizes Ozempic EU-wide

The European Commission granted a marketing authorization valid across the European Union for Ozempic (semaglutide) on February 8, 2018, clearing the once-weekly injection for adults with type 2 diabetes ^[1]. The decision came roughly two months after the US Food and Drug Administration approved the same product; the European Medicines Agency's public assessment page covers only the EU review and does not describe the US timeline ^[1].

The EU authorization was narrower than what many people associate with semaglutide today. Ozempic was approved as a diabetes medicine used together with diet and exercise in adults whose type 2 diabetes is not satisfactorily controlled ^[1]. It could be used on its own in people who cannot take metformin, or added on to other diabetes medicines ^[1]. Weight loss was described as a benefit seen in the trials, not as an approved use on its own ^[1].

What the EU regulators reviewed

Five studies in more than 4,000 patients showed Ozempic lowered HbA1c — a measure of average blood sugar — by between 1.2 and 1.8 percentage points over 10 to 13 months ^[1]. In those same studies, comparison treatments produced smaller reductions: sitagliptin 0.55 percentage points, exenatide 0.92, and insulin glargine 0.83, while placebo reduced HbA1c by up to 0.09 percentage points ^[1]. The results also indicated that treatment was associated with a beneficial fall in body weight ^[1].

A separate cardiovascular study in more than 3,000 people with diabetes at high risk of heart problems found that heart attack, stroke or death occurred in 6.6% of patients on Ozempic versus 8.9% on placebo ^[1]. Looking at the three outcomes separately, fewer patients on Ozempic had a heart attack or a stroke, but rates of death from heart problems were similar in the two groups ^[1].

On dosing, the EU product information at authorization described a starting dose of 0.25 mg once a week, an increase to 0.5 mg after four weeks, and a further increase if needed up to a maximum of 1 mg once weekly ^[1]. The medicine is a solution for injection in prefilled pens, available only by prescription, and injected under the skin of the belly, thigh or upper arm ^[1]. Semaglutide is a GLP-1 receptor agonist, meaning it acts like the gut hormone GLP-1 by increasing the insulin the pancreas releases in response to food ^[1].

Safety findings flagged at approval

The most common side effects — those that may affect more than 1 in 10 people — were digestive problems including diarrhea, vomiting and nausea, which the EMA described as mild or moderate and short in duration ^[1]. Serious worsening of diabetic retinopathy, damage to the light-sensitive membrane at the back of the eye, was listed as common, meaning it may affect up to 1 in 10 people ^[1]. Regulators said the overall safety profile was in line with other medicines in the same class, that digestive side effects were considered manageable, and that the retinopathy signal would be further investigated ^[1].

Why it matters for patients

For US readers, the EU decision is mostly context, but useful context. It shows that two independent regulators looked at the same semaglutide trial package in late 2017 and early 2018 and reached similar conclusions about benefit and risk ^[1]. The numbers in the EU summary — the HbA1c drops, the head-to-head comparisons, the 6.6% versus 8.9% cardiovascular result — are the same evidence base that underpins how clinicians talk about Ozempic today ^[1].

It also marks how much the labeled use has shifted. In February 2018, the approved EU maximum dose was 1 mg weekly and weight loss was a secondary observation rather than an indication ^[1]. The EMA page does not address later changes to dosing, indications or supply, so anything beyond the 2018 authorization is not covered by this source.

What happens next

The authorization took effect EU-wide on February 8, 2018, and the EMA published its plain-language summary and product information for the public on February 21, 2018 ^[1]. The agency said recommendations and precautions for safe use were built into the summary of product characteristics and package leaflet, with the retinopathy question set for further study ^[1].