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Suliqua®1 obtains expanded indication across Europe - Authorized for use in adults with type 2 diabetes in addition to metformin, with or without SGLT-2 inhibitor
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March 16, 2020 Paris, France

Suliqua®1 obtains expanded indication across Europe

Authorized for use in adults with type 2 diabetes in addition to metformin, with or without SGLT-2 inhibitor

The European Commission has granted an extended therapeutic indication for use of

Suliqua® (insulin glargine 100 Units/mL and lixisenatide) in the European Economic Area

(EEA)2 as an adjunct to diet and exercise to improve glycemic control in adults with

insufficiently controlled type 2 diabetes (T2D), in addition to metformin with or without

SGLT-2inhibitors. TherevisedindicationnowalsoallowsuseofSuliquawhenweeklyor

daily GLP-1 RA do not deliver sufficient blood sugar control. This decision follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in January 2020.

“Because everyone with diabetes has different needs, Sanofi believes it is essential to offer a wide range of treatment options, so people can work with their physicians to find the individualized treatment plan that best meets their needs,” says David Werner, Head of Global Insulins at Sanofi. “We are delighted that this new indication enables prescribers to consider Suliqua as a treatment option for more people earlier in their journey with type 2 diabetes.

This new indication is broader than the previous label for Suliqua and will enable it to be used as a first injectable treatment for a wider population of adults with T2D across


Today, 50-70% of people with type 2 diabetes do not achieve globally recommended

blood sugar targets, whether using oral treatments (OADs) or after initiating injectable

therapy (basal insulin or GLP-1 RA). For these people, who often remain uncontrolled

with elevated blood sugar for long periods, concerns over hypoglycemia, tolerability and body weight drive hesitancy to intensify therapy as is recommended by international



  1. Soliqua® (insulin glargine 100 Units/mL and lixisenatide) is marketed as Suliqua® in the EEA. It is marketed as Soliqua® 100/33 in the U.S., and as Soliqua® in other geographies where it is approved.

  2. The EEA comprises the European Union, Iceland, Liechtenstein and Norway.

  3. Sanofi, Suliqua Summary of Product Characteristics, available via

    Accessed March 2020].

Europe. The extended indication is based on the data from the LixiLan-G clinical trial, which demonstrate an integral effect to control blood sugar control overnight (FPG) and after meals (PPG).

Background: The need for additional treatment options for people with T2D

intensification of over 3.5 years.
option for people with T2D, where potential tolerability barriers can be balanced to deliver therapeutic efficacy, and which remains simple to use without disrupting lifestyles.

Reluctance to change treatment results in a median time from initiation to


This highlights the need for a more efficient treatment

Sanofi Diabetes Update

  1. Blonde L, et al. Diabetes care. 2019;42(11):2108-16, DOI: 10.2337/dc19-1357.

  2. Esposito K et al. Diabetes Obes Metab. 2012; 14(3):228-33.

  3. Polonsky WH et al. Diabetes Care 2005; 28(10):25432545.

  4. Funnell MM et al. Clinical Diabetes 2007; 25:3638.

  5. Khunti, K et al. Diabetes Obes Metab. 2016; 18:401-409.

  6. Khunti K et al. Diabetes Care 2013; 36(11):34113417.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Global Diabetes Communications

Serge Spierckel
Tel.: +33 (0) 

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