Forxiga

dapagliflozin

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Forxiga. 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 Forxiga.

: Forxiga is a medicine that contains the active substance dapagliflozin. It is available as tablets (5 and 10 mg).

: Forxiga is used to treat adults with type-2 diabetes.
Forxiga can be used on its own in patients whose blood glucose (sugar) levels are not satisfactorily controlled on diet and exercise alone and who cannot tolerate metformin (another antidiabetes medicine).
Forxiga can also be used as an ‘add-on’ to other antidiabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of the diabetes.
The medicine can only be obtained with a prescription.

: The recommended dose of Forxiga is 10 mg once a day. If Forxiga is used in combination with insulin or 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 Forxiga are dependent on kidney function, the effectiveness of the medicine is reduced in patients with reduced kidney function.
Therefore, the use of Forxiga is not recommended in patients with moderately or severely reduced kidney function. For patients with severely reduced liver function a starting dose of 5 mg is recommended.

: 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 Forxiga, 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, Forxiga causes more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood.

: The effects of Forxiga were first tested in experimental models before being studied in humans.
Forxiga on its own has been compared with placebo (a dummy treatment) in two studies in 840 patients. A third study compared Forxiga with a sulphonylurea (glipizide), both taken in combination with metformin in 814 patients. Four other studies compared Forxiga 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 (HbA1c), which gives an indication of how well the blood glucose is controlled.

: Forxiga was more effective than placebo at reducing the levels of HbA1c when used alone and in combination with other antidiabetes medicines. When Forxiga was used on its own at a dose of 10 mg, it decreased HbA1c levels by 0.66% more than placebo after 24 weeks. When Forxiga was added to other antidiabetes medicines, Forxiga 10 mg decreased HbA1c levels by 0.54-0.68% more than placebo after 24 weeks.
When compared with a sulphonylurea, Forxiga was at least as effective and both medicines reduced HbA1c levels by 0.52% after 52 weeks.

: The most common side effect with Forxiga (seen in more than 1 patient in 10) is hypoglycaemia when used with a sulphonylurea or insulin. For the full list of side effects reported with Forxiga, see the package leaflet.
Forxiga must not be used in people who are hypersensitive (allergic) to dapagliflozin or any of the other ingredients.

: The CHMP concluded that Forxiga was shown to be effective in lowering blood glucose levels in patients with type-2 diabetes, when given alone or in combination with other antidiabetes medicines with different mechanisms of actions. In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Forxiga.
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 Forxiga 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 Forxiga did not show this risk.
The Committee has recommended that further studies be carried out to investigate this concern. The CHMP concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Forxiga on 12 November 2012.
For more information about treatment with Forxiga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Forxiga : EPAR - Summary for the public (PDF/56.97 KB)

First published: 07/12/2012
Last updated: 07/12/2012
EMA/280091/2012
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More detail is available in the summary of product characteristics

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Name	Forxiga
Agency product number	EMEA/H/C/002322
Active substance	dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name	dapagliflozin
Therapeutic area (MeSH)	Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code	A10BK01

Publication details
Marketing-authorisation holder	AstraZeneca AB
Revision	13
Date of issue of marketing authorisation valid throughout the European Union	11/11/2012
Contact address	151 85 Sodertalje Sweden

Product information

12/11/2018 Forxiga - EMEA/H/C/002322 - WS/1380

List item

Forxiga : EPAR - Product Information (PDF/255.14 KB)

First published: 07/12/2012
Last updated: 05/12/2018
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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.

List item

Forxiga : EPAR - All Authorised presentations (PDF/23.66 KB)

First published: 07/12/2012
Last updated: 07/12/2012
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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Forxiga is indicated in adults aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control as:

monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance;
add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

List item

Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/193.94 KB)

First published: 16/09/2013
Last updated: 05/12/2018
List item

Forxiga-H-C-PSUSA-00010029-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.22 KB)

First published: 27/07/2017
Last updated: 27/07/2017
EMA/465597/2017
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Forxiga-H-A20-1442-C-2322-0029 : EPAR - Assessment Report - Article 20 (PDF/254.07 KB)

Adopted

First published: 05/07/2017
Last updated: 05/07/2017
EMA/PRAC/637349/2016
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Forxiga-H-A20-1442-C-2322-0029 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

First published: 05/07/2017
Last updated: 05/07/2017
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  (PDF/84.18 KB)
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  (PDF/76.27 KB)
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Forxiga-H-C-2322-A20-1419-0021 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Adopted

First published: 18/05/2016
Last updated: 18/05/2016
EMA/PRAC/50218/2016
List item

Forxiga : EPAR - Scientific Conclusion (PDF/44.81 KB)

First published: 18/05/2016
Last updated: 18/05/2016
- Bulgarian
  (PDF/78.43 KB)
- Croatian
  (PDF/70.99 KB)
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  (PDF/76.84 KB)
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List item

Forxiga-H-C-2322-P46-016 : EPAR - Assessment report (PDF/1.11 MB)

Adopted

First published: 05/01/2016
Last updated: 05/01/2016
EMA/CHMP/784877/2015

Forxiga

Table of contents

Overview

Forxiga : EPAR - Summary for the public (PDF/56.97 KB)

Authorisation details

Product information

Forxiga : EPAR - Product Information (PDF/255.14 KB)

Contents

Forxiga : EPAR - All Authorised presentations (PDF/23.66 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/193.94 KB)

Forxiga-H-C-PSUSA-00010029-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.22 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Assessment Report - Article 20 (PDF/254.07 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

Forxiga-H-C-2322-A20-1419-0021 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Forxiga : EPAR - Scientific Conclusion (PDF/44.81 KB)

Forxiga-H-C-2322-P46-016 : EPAR - Assessment report (PDF/1.11 MB)

Initial marketing-authorisation documents

Forxiga : EPAR - Public assessment report (PDF/2.23 MB)

CHMP summary of positive opinion for Forxiga (PDF/57.03 KB)

News

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Forxiga

Table of contents

Overview

Forxiga : EPAR - Summary for the public (PDF/56.97 KB)

Authorisation details

Product information

Forxiga : EPAR - Product Information (PDF/255.14 KB)

Contents

Forxiga : EPAR - All Authorised presentations (PDF/23.66 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/193.94 KB)

Forxiga-H-C-PSUSA-00010029-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.22 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Assessment Report - Article 20 (PDF/254.07 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

Forxiga-H-C-2322-A20-1419-0021 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Forxiga : EPAR - Scientific Conclusion (PDF/44.81 KB)

Forxiga-H-C-2322-P46-016 : EPAR - Assessment report (PDF/1.11 MB)

Initial marketing-authorisation documents

Forxiga : EPAR - Public assessment report (PDF/2.23 MB)

CHMP summary of positive opinion for Forxiga (PDF/57.03 KB)

News

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