European Commission authorizes Ozempic for type 2 diabetes across the EU

The European Commission granted Ozempic a marketing authorization valid throughout the European Union on 8 February 2018, clearing the semaglutide injection for adults with type 2 diabetes ^[1]. The European Medicines Agency's public assessment summary for the drug was first published on 21 February 2018 ^[1].

Ozempic is a once-weekly injection sold in prefilled pens and available only by prescription; patients inject it under the skin of the belly, the thigh or the upper arm ^[1]. Its active substance, semaglutide, is a GLP-1 receptor agonist. It acts like GLP-1, a hormone produced in the gut, by increasing the amount of insulin the pancreas releases in response to food, which helps control blood glucose ^[1]. Under the EU authorization it is used with diet and exercise, either on its own in patients who cannot take metformin or as an add-on to other diabetes medicines ^[1].

The authorization rested mainly on five studies that together enrolled more than 4,000 patients. In those trials, Ozempic lowered HbA1c, a measure of average blood glucose, by 1.2 to 1.8 percentage points over 10 to 13 months. The comparison treatments did less: sitagliptin lowered HbA1c by 0.55 percentage points, exenatide by 0.92 and insulin glargine by 0.83, while placebo lowered it by up to 0.09 points. The results also indicated a beneficial fall in body weight ^[1].

A separate study followed more than 3,000 diabetes patients at high risk of heart problems. Heart attack, stroke or death occurred in 6.6 percent of patients treated with Ozempic and 8.9 percent of those given placebo. Looking at the three events separately, fewer Ozempic patients had a heart attack or a stroke, but rates of death from heart problems were similar in the two groups ^[1].

On safety, the most common side effects, affecting more than 1 in 10 people, involve the digestive system, including diarrhea, vomiting and nausea. The agency described these as mild or moderate in severity and of short duration. Serious worsening of diabetic retinopathy, damage to the light-sensitive membrane at the back of the eye, is common and may affect up to 1 in 10 people ^[1]. The European Medicines Agency concluded that the benefits of Ozempic outweighed its risks and recommended approval ^[1].

The EU authorization covers type 2 diabetes. The assessment summary does not describe Ozempic as a weight-loss medicine, and it does not state how many patients stopped treatment during the trials ^[1].

Why it matters for patients

The 2018 European decision means semaglutide went through a second full regulatory review, weighing the same kinds of evidence: blood sugar reductions over roughly a year, and a trial that tracked heart attacks, strokes and deaths ^[1]. Several details of that review are worth knowing.

The heart result is not a single number. Fewer heart attacks and strokes occurred in the Ozempic group, but deaths from heart problems were similar between the two groups, according to the summary ^[1].

Worsening diabetic retinopathy is listed as a common serious effect, affecting up to 1 in 10 people ^[1]. That finding concerns people who already have diabetes-related eye damage, and it is one of the reasons the medicine's labeling carries precautions.

Digestive side effects were the most frequently reported problem. Nausea, vomiting and diarrhea affected more than 1 in 10 people, though the agency called them mild or moderate and short-lived ^[1].

Where a patient lives also matters. The authorization is valid across all EU member states, while the summary describes only the European regulatory decision and does not address availability or labeling outside the EU ^[1]. The assessment does not report results beyond the 10 to 13 months covered by the main trials, so long-term outcomes in these studies have not been disclosed ^[1].

What happens next

The agency said the worsening of diabetic retinopathy seen in patients taking Ozempic "will be further investigated" ^[1]. The public assessment summary does not give a date for that follow-up or describe what it will involve. No other post-authorization milestones are listed in it ^[1].