This document is a summary of the European Public Assessment Report (EPAR) for Ozempic.
It explains how the Agency’s evaluation of the medicinal product led it to recommend its authorisation in the EU and its conditions of use.
recommended its authorisation in the EU and its conditions of use. It is not intended to
provide practical advice on how to use Ozempic.
For practical information on the use of Ozempic, patients should read the package insert or contact their doctor or pharmacist.
or contact their doctor or pharmacist.
What is Ozempic and what is it used for?
Ozempic is a diabetes medicine used in addition to diet and exercise to treat adults with
to treat adults with uncontrolled type 2 diabetes.
is not adequately controlled.
Ozempic can be used alone in patients who cannot take metformin (another diabetes medication).
diabetes medication). It can also be used as an “add-on” to other diabetes medicines.
Ozempic contains the active ingredient semaglutide.
How is Ozempic used?
Ozempic is available as an injectable solution in pre-filled pens and is only available on
prescription only. It is injected under the skin of the stomach, thigh or upper arm.
The initial dose of Ozempic is 0.25 mg once a week. After four weeks, the dose should be increased to
increased to 0.5 mg. If necessary, the dose can be further increased to a maximum of 1 mg,
once a week. For more information, see the package insert.
How does Ozempic work?
The active ingredient in Ozempic, semaglutide, is a “GLP-1 receptor agonist”. It works in the same way as
the same way as GLP-1 (a hormone produced in the gut), by increasing the amount of insulin
released by the pancreas after food intake. This action helps to control blood
glucose levels in the blood.
What benefits has Ozempic shown in studies?
Studies have shown that Ozempic is effective in lowering blood glucose levels and reducing
health complications in patients with type 2 diabetes.
Five studies involving more than 4,000 patients showed that Ozempic reduced HbA1c
(a measure of glucose in the blood) within a range of 1.2 to 1.8 percentage points
over a period of 10 to 13 months. In these studies, compared to other treatments, namely
sitagliptin, exenatide and insulin glargine (which resulted in reductions of 0.55, 0.92, 0.83 percentage points
percentage points respectively) and placebo (reductions of up to 0.09 percentage points),
Ozempic performed better. In addition, the results showed that treatment with Ozempic
was associated with a beneficial reduction in body weight.
Another study in more than 3,000 patients with diabetes and a high risk of heart problems showed that, with Ozempic
heart problems showed that, in general, a heart attack, stroke or death was not associated with
death occurred less frequently in patients treated with Ozempic
(6.6%) compared to placebo patients (8.9%). When looking at the three “events” separately, fewer patients on Ozempic
events” separately, fewer Ozempic patients had a heart attack or stroke, but death rates were
stroke, but the rates of death due to heart problems were similar in both groups.
What are the risks associated with using Ozempic?
The most common side effects seen with Ozempic (which may affect more than 1 in 10 people) include
more than 1 in 10 people) include digestive system disorders such as diarrhea, vomiting and nausea (which can be
vomiting and nausea (sickness). They are mild to moderate in intensity and short in duration.
duration. Serious worsening of diabetic retinopathy (damage to the retina, the light-sensitive membrane at the back of the eye)
serious worsening of diabetic retinopathy (damage to the retina, the light-sensitive membrane at the back of the eye) is common (up to one in 10 people).
For a full description of the side effects and limitations of Ozempic, see the
Why is Ozempic approved?
Ozempic has been shown to be effective in controlling blood glucose levels. Treatment with
Ozempic also resulted in weight loss, which is considered beneficial in
patients with diabetes. Ozempic has also been shown to be effective in reducing the occurrence of
complications of diabetes, such as heart attacks and strokes.
In terms of safety, this was considered to be consistent with other drugs in the same class.
drugs in the same class. Adverse events affecting the gastrointestinal system are considered
considered manageable. Worsening of diabetic retinopathy was also observed and will be further studied.
be further investigated.
The European Medicines Agency considered that the benefits of Ozempic observed in the studies outweighed the risks and recommended that Ozempic be used in a
studies outweighed the risks and recommended that Ozempic be approved for use in the EU.
What steps are being taken to ensure the safe and effective use of Ozempic?
Recommendations and precautions for healthcare professionals and patients to ensure the safe and effective use of Ozempic
and patients to ensure the safe and effective use of Ozempic have been included in the summary of
product characteristics and in the package insert