Bydureon

exenatide

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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 and what is it used for?

Bydureon is a diabetes medicine used together with other diabetes medicines including long-acting insulin to treat adults with type 2 diabetes whose blood glucose (sugar) levels are not adequately controlled with the other medicines.

Bydureon contains the active substance exenatide.

How is Bydureon used?

Bydureon is available as a powder and solvent that are mixed together to make a prolonged-release suspension for injection providing 2 mg of exenatide. Prolonged-release means that the active substance is released slowly after being injected.

Bydureon is given by 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 pioglitazone does not cause hypoglycaemia.

Patients using both Bydureon and insulin should inject the medicines separately.

The medicine can only be obtained with a prescription.

How does Bydureon work?

In type 2 diabetes, the pancreas does not make enough insulin to control the level of glucose in the blood or the body is unable to use insulin effectively. This leads to excess glucose in the blood.

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.

What benefits of Bydureon have been shown in studies?

Bydureon was effective at controlling blood glucose in six main studies involving nearly 2700 patients with type 2 diabetes. In all of the studies, the main measure of effectiveness was the reduction in the amount of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

The first two studies (in a total of 555 patients) compared Bydureon with another medicine also containing exenatide but given twice daily, both given as add-on treatment to oral diabetes medicines or diet and exercise alone. At the start of the studies, the patients’ HbA1c levels were around 8.4%. In the first study, Bydureon reduced HbA1c 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.

The third study (in 514 patients) compared Bydureon with sitagliptin or pioglitazone as add-on treatment to metformin. At the start of the study, the patients’ HbA1c levels were around 8.5%. Bydureon reduced HbA1c levels by an average of 1.4 points after 26 weeks of treatment, compared with an average reduction of 0.8 and 1.1 points with sitagliptin and pioglitazone respectively.

The fourth study (in 456 patients) compared Bydureon with insulin glargine (a long-acting insulin) as add-on treatment to metformin with or without a sulphonylurea. At the start of the study, the patients’ HbA1c levels were around 8.3%. The average reduction with Bydureon was 1.5 points after 26 weeks, compared with an average reduction of 1.3 points with insulin glargine.

In the fifth study (in 695 patients), Bydureon given with dapagliflozin was compared with Bydureon alone and dapagliflozin alone. All patients were also taking metformin. At the start of the study, the patients’ HbA1c levels were around 9.3%. The average reduction with Bydureon plus dapagliflozin was 2.0 points after 28 weeks, compared with an average reduction of 1.6 points with Bydureon alone and 1.4 points with dapagliflozin alone.

In the sixth study (in 464 patients), Bydureon given together with insulin glargine with or without metformin was compared with placebo (dummy treatment) also given with insulin glargine with or without metformin. At the start of the study, the patients’ HbA1c levels were around 8.5%. The average reduction with Bydureon was 1.0 point after 28 weeks, compared with an average reduction of 0.2 points with placebo.

What are the risks associated with Bydureon?

The most common side effects with Bydureon are nausea (feeling sick) and diarrhoea. Nausea occurs mainly at the start of treatment and decreases over time. In addition, reactions at the site of injection (itching and redness), low blood sugar levels (when used with a sulphonylurea) and headache occur. Most side effects are mild to moderate in intensity. For the full list of side effects and restrictions with Bydureon, see the package leaflet.

Why is Bydureon approved?

The European Medicines Agency 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 Agency 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?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bydureon have been included in the summary of product characteristics and the package leaflet.

Other information about Bydureon

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

For more information about treatment with Bydureon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Bydureon : EPAR - Summary for the public BG = bălgarski 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public ES = español 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public CS = čeština 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public DA = dansk 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public DE = Deutsch 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public ET = eesti keel 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public EL = elliniká 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public EN = English 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public FR = français 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public IT = italiano 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public LV = latviešu valoda 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public LT = lietuvių kalba 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public HU = magyar 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public MT = Malti 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public NL = Nederlands 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public PL = polski 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public PT = português 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public RO = română 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public SK = slovenčina 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public SL = slovenščina 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public FI = suomi 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public SV = svenska 2011-07-05 2018-01-19
Bydureon : EPAR - Summary for the public HR = Hrvatski 2011-07-05 2018-01-19

This EPAR was last updated on 19/01/2018 .

Authorisation details

Product details

Product details for Bydureon
NameBydureon
Agency product numberEMEA/H/C/002020
Active substance

exenatide

International non-proprietary name (INN) or common name

exenatide

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BJ01

Publication details

Publication details for Bydureon
Marketing-authorisation holder

AstraZeneca AB

Revision13
Date of issue of marketing authorisation valid throughout the European Union17/06/2011

Contact address:

AstraZeneca AB
151 85 Södertälje
Sweden

Product information

Product information

10/11/2017  Bydureon -EMEA/H/C/002020 -II/0045

Name Language First published Last updated
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19
Bydureon : EPAR - Product Information HR = Hrvatski 2011-07-05 2018-01-19

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11
Bydureon : EPAR - All Authorised presentations HR = Hrvatski 2011-07-05 2015-05-11

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including basal insulin when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Bydureon : EPAR - Public assessment report HR = Hrvatski 2011-07-05  
CHMP summary of positive opinion for Bydureon HR = Hrvatski 2011-04-15