BYDUREON 2 mg powder and solvent for prolonged-releasesuspension for injection

Bydureon is a medicine that contains the active substance exenatide. It is available as a powder and solvent to be made up into a prolonged-release suspension for injection that provides 2 mg of exenatide. Prolonged-release means that the active substance is released slowly over a few weeks after being injected.

Bydureon is used to treat type 2 diabetes. It is used together with other antidiabetes medicines in adult patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines. It can be used with metformin, a sulphonylurea, a thiazolidinedione, metformin and a sulphonylurea, or metformin and a thiazolidinedione.

The medicine can only be obtained with a prescription.

Bydureon is given as one injection under the skin once a week on the same day each week in the abdomen, thigh or back of the upper arm. Patients inject themselves using a kit supplied with the medicine. They should be given appropriate training and should follow the user instructions.

When adding Bydureon to a sulphonylurea, the doctor may need to reduce the dose of the sulphonylurea because there is a risk of hypoglycaemia (low blood sugar levels). Adding Bydureon to metformin or a thiazolidinedione is not associated with this risk.

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Bydureon, exenatide, is an ?incretin mimetic?. This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food. This helps with the control of blood glucose levels.

The effects of Bydureon were first tested in experimental models before being studied in humans.

Bydureon was investigated in four main studies lasting six months or more involving a total of 1,525 patients with type 2 diabetes. Two of the studies (555 patients) compared Bydureon with a medicine containing exenatide given twice daily, as add-on treatment to oral antidiabetes medicines or diet and exercise alone. One study (514 patients) compared Bydureon with sitagliptin or pioglitazone (a thiazolidinedione) as add-on treatment to metformin. The other study (456 patients) compared Bydureon with insulin glargine as add-on treatment to metformin with or without a sulphonylurea.

In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is being controlled. At the start of the studies, the patients? HbA1c levels were around 8.4%.

In all four studies, Bydureon was more effective than the comparator treatments at reducing the levels of HbA1c in the blood. In the first study, Bydureon reduced HbA1c levels by an average of 1.9% after 30 weeks of treatment, compared with an average reduction of 1.5% with exenatide given twice daily. In the second study, the average reduction was 1.6% after 24 weeks of treatment with Bydureon, compared with an average reduction of 0.9% with exenatide given twice daily. In the third study, Bydureon reduced HbA1c levels by an average of 1.4% after 26 weeks of treatment, compared with an average reduction of 0.8% or 1.1% with sitagliptin or pioglitazone respectively. In the fourth study, the average reduction with Bydureon was 1.5% after 26 weeks, compared with an average reduction of 1.3% with insulin glargine.

The most common side effects seen with Bydureon were mainly problems affecting the stomach and gut (nausea (feeling sick), vomiting, diarrhoea and constipation). Nausea was the most common single side effect, which was mainly seen at the start of treatment and decreased over time. In addition, reactions at the site of injection (itching), low blood sugar levels (when used with a sulphonylurea) and headache occurred. Most side effects were mild to moderate in intensity. For the full list of all side effects reported with Bydureon, see the package leaflet.

Bydureon should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.

Bydureon Page

The CHMP noted that the benefits of Bydureon, such as its effect on reducing the levels of HbA1c, compare well with those of comparator medicines and that its side effects are manageable. The CHMP therefore decided that Bydureon?s benefits are greater than its risks and recommended that it be given marketing authorisation.