Human medicines European public assessment report (EPAR): Suliqua, insulin glargine,lixisenatide, Date of authorisation: 11/01/2017, Revision: 15, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Suliqua is a medicine that is used together with metformin (another diabetes medicine), with or without SGLT-2 inhibitors (other diabetes medicines), for the treatment of adults with type 2 diabetes. It is used with appropriate diet and exercise to improve control of blood glucose (sugar) when the diabetes is not satisfactorily controlled.

The active substances in Suliqua are insulin glargine and lixisenatide.

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How is Suliqua used?

Suliqua is available as pre-filled disposable pens in two different strengths and can only be obtained with a prescription. It is given by injection under the skin of the belly, the thigh or the upper arm.

Suliqua is given once a day up to 1 hour before a meal, preferably at the same time each day. Before Suliqua is started, the patient’s insulin and diabetes medicines other than metformin and SGLT-2 inhibitors should be stopped. The dose is adjusted individually for each patient according to the patient’s blood glucose.

For more information about using Suliqua, see the package leaflet or contact your doctor or pharmacist.

How does Suliqua work?

Type 2 diabetes is a disease in which the level of blood glucose is high because either the body does not produce enough insulin, or the body is unable to use insulin effectively.

One of the active substances in Suliqua, insulin glargine, is a replacement insulin that acts in the same way as the body’s own insulin and helps glucose enter cells from the blood, thereby controlling the level of glucose in the blood. Insulin glargine reaches the bloodstream more slowly than human insulin after an injection and its action therefore lasts longer.

The other active substance in Suliqua, lixisenatide, belongs to the class of medicines known as GLP-1 agonists. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps to control blood glucose levels.

By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

What benefits of Suliqua have been shown in studies?

Suliqua was effective at controlling blood glucose in three main studies in patients with type 2 diabetes. The main measure of effectiveness in all three studies was the change in the blood levels of a substance called glycosylated haemoglobin (HbA1c). HbA1c gives an indication of how well blood glucose is controlled: a reduction in HbA1c levels indicates improved control of blood glucose levels. The first two studies looked at the change in HbA1c after 30 weeks, and the third study looked at the change after 26 weeks.

The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin with or without another diabetes medicine taken by mouth. After stopping their diabetes medicines given by mouth except metformin, patients were given Suliqua or one of its two components, insulin glargine or lixisenatide. Results showed that Suliqua is more effective at controlling blood glucose levels than either component: average HbA1c at the start of the study was 8.1%, which fell after 30 weeks of treatment to 6.5% in the group using Suliqua, compared with 6.8% in the group using insulin glargine and 7.3% in the group using lixisenatide.

The second study involved 736 patients whose blood glucose was not adequately controlled by a long-acting insulin such as insulin glargine with or without one or two other diabetes medicines taken by mouth. After stopping all diabetes medicines given by mouth except metformin, patients were given either Suliqua or insulin glargine. Average HbA1c was 8.1% before patients started taking Suliqua or insulin glargine. After 30 weeks of treatment, average HbA1c fell to 6.9% in the group taking Suliqua and to 7.5% in patients receiving insulin glargine.

The third study involved 514 patients whose blood glucose was not adequately controlled by metformin (alone or with other diabetes medicines taken by mouth) in combination with a diabetes medicine belonging to the class of GLP-1 agonists. Half of the patients were switched from their GLP-1 agonist medicine to Suliqua. After 26 weeks of treatment, average HbA1c dropped from 7.7% to 6.7% in the group treated with Suliqua and from 7.8% to 7.4% in the group that continued using a GLP-1 agonist.

What are the risks associated with Suliqua?

The most common side effect with Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); problems with the digestive system are common and include diarrhoea, vomiting and nausea (feeling sick). For the full list of all side effects and restrictions with Suliqua, see the package leaflet.

Why is Suliqua authorised in the EU?

The European Medicines Agency (EMA) decided that Suliqua’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The Agency concluded that combination treatment with a long-acting insulin and a GLP-1 agonist such as Suliqua is an important option for patients with type 2 diabetes who are eligible for insulin or who need intensive insulin therapy. In these patients, Suliqua was effective at controlling glucose levels and reduced the risk of problems linked to intensive insulin therapy such as hypoglycaemia and weight gain. In terms of safety there were no new safety concerns with the combination of insulin glargine and lixisenatide in Suliqua compared with the components used separately.

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

The company that markets Suliqua will provide educational materials for healthcare professionals and patients, explaining how to use the medicine safely, so as to reduce the risk of medication errors.

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

As for all medicines, data on the use of Suliqua are continuously monitored. Side effects reported with Suliqua are carefully evaluated and any necessary action taken to protect patients.

Other information about Suliqua

Suliqua received a marketing authorisation valid throughout the EU on 11 January 2017.

Suliqua : EPAR - Medicine overview

Reference Number:

EMA/82164/2020

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Product information

Suliqua : EPAR - Product Information

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Latest procedure affecting product information:

VR/0000334815

01/07/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Suliqua : EPAR - All Authorised presentations

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Product details

Name of medicine

Suliqua

Active substance

• insulin glargine
• lixisenatide

International non-proprietary name (INN) or common name

• insulin glargine
• lixisenatide

Therapeutic area (MeSH)

Diabetes Mellitus, Type 2

Anatomical therapeutic chemical (ATC) code

A10AE54

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.

Authorisation details

EMA product number

EMEA/H/C/004243

Marketing authorisation holder

Sanofi Winthrop Industrie

82 Avenue Raspail 94250 Gentilly FRANCE

Opinion adopted

10/11/2016

Marketing authorisation issued

11/01/2017

Revision

15

Assessment history

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Changes since initial authorisation of medicine

Suliqua : EPAR - Procedural steps taken and scientific information after authorisation

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Suliqua : EPAR - Procedural steps taken and scientific information after authorisation (archive)

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Suliqua-H-C-PSUSA-00010577-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/725796/2022

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First published:

05/09/2022

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Suliqua-H-C-4243-II-0011: EPAR - Assessment Report- Variation

Adopted

Reference Number:

EMA/CHMP/82348/2020

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First published:

24/03/2020

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Suliqua-H-C-PSUSA-00010577-201905 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/122177/2020

English (EN) (132.67 KB - PDF)

First published:

09/03/2020

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CHMP post-authorisation summary of positive opinion for Suliqua (II-11)

Adopted

Reference Number:

EMA/CHMP/41157/2020

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First published:

31/01/2020

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Initial marketing authorisation documents

Suliqua : EPAR - Public assessment report

Adopted

Reference Number:

EMA/800280/2016

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CHMP summary of positive opinion for Suliqua

Adopted

Reference Number:

EMA/CHMP/715538/2016

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11/11/2016

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11/11/2016

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News on Suliqua

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024

12/04/2024

EMA statement on ongoing review of GLP-1 receptor agonists

11/07/2023

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020

31/01/2020

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016

11/11/2016

Preventing medication errors

Suliqua: Educational materials for healthcare professionals and patients using the diabetes medicine Suliqua

Reference Number:

EMA/747766/2016

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