Victoza

liraglutide

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Victoza?

Victoza is a solution for injection that contains the active substance liraglutide. It is available in prefilled pens (6 mg/ml).

What is Victoza used for?

Victoza is used in adults who have type-2 diabetes (non-insulin-dependent diabetes) to control their blood glucose (sugar) level. Victoza is used together with:

• metformin or a sulphonylurea (antidiabetes medicines) in patients whose glucose levels are not satisfactorily controlled on metformin or a sulphonylurea used on their own at the maximum possible dose;
• metformin and a sulphonylurea, or metformin and a thiazolidinedione (another group of antidiabetes medicines) in patients whose glucose levels are not satisfactorily controlled despite treatment with two medicines).

The medicine can only be obtained with a prescription.

How is Victoza used?

Victoza is administered by the patient once a day by subcutaneous injection (under the skin) in the abdomen, thigh or upper arm. It is given independently of meals and preferably at the same time each day.

The starting dose of Victoza is 0.6 mg. After at least one week, the dose is increased to 1.2 mg. In some patients, the dose can be further increased to 1.8 mg one week later to achieve better control of blood glucose.

When Victoza is added to existing treatment containing metformin or a thiazolidinedione, the doses of these medicines do not have to be changed. When Victoza is added to treatment with a sulphonylurea, the doctor should consider lowering the dose of the sulphonylurea to reduce the risk of having hypoglycaemia (low blood glucose).

How does Victoza work?

Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Victoza, liraglutide, 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.

How has Victoza been studied?

The effects of Victoza were first tested in experimental models before being studied in humans. Victoza was investigated in five main studies involving 3,978 adults with type-2 diabetes:

• one ‘monotherapy’ study, comparing Victoza on its own with glimepiride (a sulphonylurea);
• two ‘dual-therapy’ studies comparing Victoza plus metformin or Victoza plus glimepiride with metformin or glimepiride taken with a placebo (a dummy treatment);
• two ‘triple-therapy’ studies comparing Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione), with treatments that included placebo or another anti-diabetes medicine instead of Victoza.

The main measure of effectiveness was the change in the amount of a substance in the blood called glycosylated haemoglobin (HbA1c) after six months or one year. HbA1c gives an indication of how well the blood glucose is controlled.

What benefit has Victoza shown during the studies?

Combinations containing Victoza were more effective at controlling blood glucose than combinations without the medicine. Dual therapies containing Victoza and metformin or a sulphonylurea led to reductions in HbA1c of around 1% compared with no reduction without Victoza. Triple therapies containing metformin and either a sulphonylurea or a thiazolidinedione led to a reduction of between 1.3 and 1.5% compared with a reduction equal or less than 0.5% without Victoza. When used alone there was also a greater reduction in HbA1c with Victoza than with glimepiride. However, the study was not sufficient to support the use of Victoza as a monotherapy.

What is the risk associated with Victoza?

The most common side effects with Victoza used in combination with other anti-diabetes medicines (seen in more than 1 patient in 10) are hypoglycaemia (low blood glucose), headache, nausea and diarrhoea. For the full list of all side effects reported with Victoza, see the package leaflet. Victoza should not be used in people who may be hypersensitive (allergic) to liraglutide or any of the other ingredients.

Why has Victoza been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Victoza’s benefits are greater than its risks for the treatment of adults with type-2 diabetes mellitus to achieve glycaemic control in dual therapy in combination with metformin or a sulphonylurea, or in triple therapy with metformin and either a sulphonylurea or a thiazolidinedione. The Committee recommended that Victoza be given marketing authorisation.

Other information about Victoza

The European Commission granted a marketing authorisation valid throughout the European Union for Victoza to Novo Nordisk A/S on 30 June 2009.

This EPAR was last updated on 25/03/2013 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

23/10/2012  Victoza -EMEA/H/C/001026 -II/0016

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.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Victoza is indicated for treatment of adults with type-2 diabetes mellitus to achieve glycaemic control:

in combination with:

• metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea;

in combination with:

• metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents