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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/44401/2016

EMEA/H/C/002020

EPAR summary for the public

Bydureon

exenatide

This is a summary of the European public assessment report (EPAR) for Bydureon. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bydureon.

What is Bydureon?

Bydureon is a diabetes medicine that contains the active substance exenatide. It is available as a powder and solvent that are mixed together to make 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.

What is Bydureon used for?

Bydureon is used to treat type 2 diabetes. It is used together with other diabetes 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.

How is Bydureon used?

Bydureon is given as one injection under the skin once a week on the same day each week in the abdomen (belly), 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.

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

How does Bydureon work?

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 to control blood glucose levels.

How has Bydureon been studied?

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 diabetes 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 (HbAlc), which gives an indication of how well the blood glucose is controlled. At the start of the studies, the patients' HbAlc levels were around 8.4%.

What benefit has Bydureon shown during the studies?

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

What is the risk associated with Bydureon?

The most common side effects seen with Bydureon were mainly problems affecting the stomach and gut (nausea (feeling sick) and diarrhoea). 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 and redness), 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 and restrictions with Bydureon, see the package leaflet.

Why has Bydureon been approved?

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.

What measures are being taken to ensure the safe and effective use of Bydureon?

A risk management plan has been developed to ensure that Bydureon is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bydureon, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Bydureon

The European Commission granted a marketing authorisation valid throughout the European Union for Bydureon on 17 June 2011.

The full EPAR for Bydureon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Bydureon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2016.

Bydureon

EMA/44401/2016

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