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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/808822/2015

EMEA/H/C/004161

EPAR summary for the public

Edistride

dapagliflozin

This is a summary of the European public assessment report (EPAR) for Edistride. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Edistride.

For practical information about using Edistride, patients should read the package leaflet or contact their doctor or pharmacist.

What is Edistride and what is it used for?

Edistride is a medicine used to treat adults with type 2 diabetes.

Edistride can be used on its own in patients whose blood glucose (sugar) levels are not satisfactorily controlled with diet and exercise alone and who cannot tolerate metformin (another diabetes medicine).

Edistride can also be used as an 'add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of the diabetes.

Edistride contains the active substance dapagliflozin. This medicine is the same as Forxiga, which is already authorised in the European Union (EU). The company that makes Forxiga has agreed that its scientific data can be used for Edistride ('informed consent').

How is Edistride used?

Edistride is available as tablets (5 and 10 mg) and can only be obtained with a prescription. The recommended dose is 10 mg once a day. If Edistride is used in combination with insulin or with medicines that make the body produce insulin, their doses may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels). As the effects of Edistride are dependent on kidney function, the effectiveness of the medicine is reduced in patients with reduced kidney function. Therefore, the use of Edistride is not recommended in patients with moderately or severely reduced

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kidney function. For patients with severely reduced liver function a starting dose of 5 mg is recommended.

How does Edistride 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. This leads to high levels of glucose in the blood.

The active substance in Edistride, dapagliflozin, works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). SGLT2 is a protein that absorbs glucose from the urine into the bloodstream as the blood is filtered in the kidneys. By blocking the action of SGLT2, Edistride causes more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood.

What benefits of Edistride have been shown in studies?

Edistride on its own has been compared with placebo (a dummy treatment) in two studies in 840 patients with type 2 diabetes. A third study compared Edistride with a sulphonylurea (glipizide), both taken in combination with metformin in 814 patients. Four other studies compared Edistride with placebo, when used as an add-on to either metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2,370 patients. In all of the studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA_1c), which gives an indication of how well the blood glucose is controlled.

Edistride was more effective than placebo at reducing the levels of HbA_1c when used alone and in combination with other diabetes medicines. When used on its own at a dose of 10 mg, it decreased HbA_1c levels by 0.66% more than placebo after 24 weeks. When Edistride was added to other diabetes medicines, Edistride 10 mg decreased HbA_1c levels by 0.54-0.68% more than placebo after 24 weeks.

When compared with a sulphonylurea, Edistride was at least as effective and both medicines reduced HbA_1c levels by 0.52% after 52 weeks.

What are the risks associated with Edistride?

The most common side effect with Edistride (seen in more than 1 patient in 10) is hypoglycaemia when used with a sulphonylurea or insulin. For the full list of side effects and restrictions with Edistride, see the package leaflet.

Why is Edistride approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Edistride's benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP concluded that Edistride was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action. In addition, beneficial reductions in weight and blood pressure were seen.

Commonly seen side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary tract infection (infection of the structures that carry urine), and are considered to be manageable. A small but higher number of bladder, breast and prostate cancer cases were seen in patients who took Edistride compared with patients who took placebo. However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Edistride did not show this risk. The Committee has nonetheless recommended that further studies be carried out to investigate this concern.

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

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

Further information can be found in the summary of the risk management plan.

Other information about Edistride

The European Commission granted a marketing authorisation valid throughout the European Union for Edistride on 9 November 2015.

The full EPAR and risk management plan summary for Edistride 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 Edistride, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2015.

Edistride

EMA/808822/2015

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