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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/256872/2015

EMEA/H/C/000309

EPAR summary for the public

Toujeo¹

insulin glargine

This document is a summary of the European Public Assessment Report (EPAR) for Toujeo. 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 Toujeo.

What is Toujeo?

Toujeo is a solution for injection that contains the active substance insulin glargine. Toujeo 300 units/ml is available in prefilled SoloStar pens. The 100 units/ml strength is approved in vials, cartridges, prefilled OptiSet pens and prefilled SoloStar pens.

What is Toujeo used for?

Toujeo 300 units/ml is used to treat diabetes in adult patients. The 100 units/ml strength is used to treat diabetes in patients aged two years or older.

The medicine can only be obtained with a prescription.

How is Toujeo used?

Toujeo is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected. The patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose.

Toujeo is given once a day. In adults (aged 18 years or over) it can be given at any time, provided that it is at the same time each day. The 100 units/ml strength should be given in the evening in patients aged less than 18 years. Toujeo can also be given together with diabetes medicines taken by mouth in patients who have type 2 diabetes.

¹ Previously known as Optisulin

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Patients can inject themselves with Toujeo if they have been trained appropriately.

Toujeo 300 units/ml and insulin glargine 100 units/ml must not be used interchangeably. This is because a given dose of Toujeo 300 units/ml does not result in the same amount of insulin in the body at the same dose of the insulin glargine 100 units/ml. The volume to be injected of Toujeo 300 units/ml is smaller in comparison with insulin glargine 100 units/ml.

When switching from insulin glargine 100 units/ml to Toujeo 300 units/ml or vice versa the dose of insulin may need to be adjusted. Care should also be taken when switching from other basal insulins to Toujeo or vice versa as the dose of insulin may need to be adjusted. Further information can be found in the summary of product characteristics (also part of the EPAR).

How does Toujeo work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Toujeo is a replacement insulin that is very similar to the insulin made by the body.

The active substance in Toujeo, insulin glargine, is slightly different from human insulin. The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Toujeo been studied?

Insulin glargine 100 units/ml was originally studied in 10 studies, in both type 1 diabetes (when the pancreas cannot produce insulin) and type 2 diabetes (when the body is unable to use insulin effectively). A total of 2,106 patients received insulin glargine 100 units/ml in all trials combined. The main studies compared insulin glargine 100 units/ml given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day. Injections of fast-acting insulin were also used at mealtimes. In one study, patients with type 2 diabetes also received antidiabetes medicines by mouth.

Further studies have also been carried out to compare insulin glargine 100 units/ml and human insulin NPH in patients with type 1 diabetes aged between five and 18 years, 200 of whom received insulin glargine 100 units/ml, and in children aged two to six years, 61 of whom received insulin glargine 100 units/ml.

Studies have also been carried out in nearly 1,400 adults with type 1 or type 2 diabetes to measure the effectiveness of insulin glargine 100 units/ml injected at any time during the day, compared with an injection given in the evening.

All of the studies measured the level of 'fasting' blood glucose (measured when the patient had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

In four more studies, the effects on the blood sugar levels of the higher strength of Toujeo (300 units/ml) were compared with those of insulin glargine 100 units/ml in 3,045 patients with either type 1 or type 2 diabetes. Additional studies (known as pharmacokinetic studies) compared the levels of insulin glargine in the blood obtained after administering the two strengths.

What benefit has Toujeo shown during the studies?

Toujeo 100 units/ml led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin. Insulin glargine 100 units/ml was effective in managing diabetes in adults and children aged two years and above. The effectiveness of insulin glargine 100 units/ml was seen regardless of the time of the injection.

In the studies comparing the two strengths of insulin glargine, Toujeo 300 units/ml strength was comparable to insulin glargine (100 units/ml) at controlling sugar levels.

What is the risk associated with Toujeo?

The most common side effect with Toujeo (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults. For the full list of side effects and restrictions with Toujeo, see the package leaflet.

Why has Toujeo been approved?

The CHMP decided that Toujeo'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 Toujeo?

A risk management plan has been developed to ensure that Toujeo 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 Toujeo, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Toujeo:

The European Commission granted a marketing authorisation valid throughout the European Union for Optisulin on 27 June 2000. The name of the medicine was changed to Toujeo on 24 April 2015.

The full EPAR for Toujeo 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 Toujeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 03-2015.