Toujeo® (insulin glargine) EU licence extended for use in adolescents and children from the age of 6 years with diabetes mellitus

Press Release

UK

Toujeo^® (insulin glargine) EU licence extended for use in adolescents and children from the age of 6 years with diabetes mellitus^[1]

• The EU licence extension of Toujeo was supported by positive results from the EDITION JUNIOR trial[2]

READING, ENGLAND – 10 January 2020 – Sanofi has announced that the European Commission (EC) has expanded the current indication for Toujeo^® (insulin glargine 300 units/mL) to include children and adolescents with diabetes.^[1] Toujeo^® is now indicated for the treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.

The new indication follows positive results in a Phase 3 trial that found children and adolescents living with type 1 diabetes achieved comparable reduction in average blood sugar (HbA1c) and similar risk of low blood sugar events with Toujeo^® when compared to insulin glargine 100 Units/mL (Gla-100).^[2]

About 36,000 children and adolescents under the age of 19 in the UK are currently living with diabetes.[3] Every year, more than 3,000 children are diagnosed with diabetes in the UK.^[3] Around 90% of children with diabetes have type 1.^[3] The incidence of type 1 diabetes is increasing by 3% each year in Europe, and the UK has one of the highest rates in the world.[4]^,[5]

Dr Alok Gupta, Consultant Paediatric and Clinical Director, Darent Valley Hospital and Co-Chair for London and South East Coast Children Diabetes Regional Networks said: “Diabetes is a long-term condition which is becoming more common in the UK. It can have a major impact on the life of a young person, as well as those around them. Based on trial data, we can see that Toujeo may present a valuable treatment for many children and adolescents living with diabetes in the UK. The licence decision is welcome news as it expands the treatment options we have available for this patient population.”

EDITION JUNIOR, is the first randomised, controlled trial comparing Toujeo^®  vs Gla-100 in this group of patients.^[2] The study met its primary endpoint of demonstrating  non-inferiority vs Gla-100 change in HbA1c from baseline at week 26. Toujeo^®  provided similar  glycemic control to Gla-100 in children and adolescents with type 1 diabetes, as well as similar risk of low blood sugar events (hypoglycemia).^[2] The percentages of patients who experienced severe hypoglycemia and who experienced high blood sugar (hyperglycemia) with ketosis were numerically lower with Toujeo^® vs Gla-100 (6% vs 8.8% and 8.2% vs 11.4%, respectively). As these are serious short-term complications, these findings may be clinically important for people with type 1 diabetes.^[2]

Professor Mike Baxter, Medical Therapy Expert for Sanofi said: “Sanofi is committed to supporting people with diabetes in controlling their condition and reaching their treatment goals. The decision to extend the licence indication to children and adolescence expands the population of patients who can benefit from Toujeo and provides a new treatment option for many young people living with diabetes.”

About Toujeo^® (Insulin glargine 300 units/mL)

Toujeo^® (insulin glargine 300 units/mL) is a solution for injection that contains the active substance insulin glargine.^[1] It is long-acting human insulin analogue indicated for the treatment of diabetes in adults, adolescents and children from the age of 6.^[1] It is available in pre-filled SoloStar^® and now DoubleStar™ pens (for those requiring at least 20 units per day).^[1]

About EDITION JUNIOR

The EDITION JUNIOR study^[2] compared Toujeo to Gla-100 in 463 children and adolescents (aged 6 to 17 years) treated for type 1 diabetes for at least one year and with HbA1c between 7.5% and 11.0% at screening.^[2] Participants continued to use their existing mealtime insulin.^[2]

The study met its primary endpoint, confirming non-inferior reduction of HbA1c with Toujeo vs Gla-100 after 26 weeks (mean reduction 0.4% vs 0.4%; difference: 0.004%, 95% CI -0.17 to 0.18; upper bound was below the pre-specified non-inferiority margin of 0.3%).^[2]

Over the same period, a comparable number of patients experienced one or more anytime (24h) documented low blood sugar (hypoglycemia) events (Toujeo 97.0% vs Gla-100 97.8%).^[2] Numerically fewer patients using Toujeo experienced severe hypoglycemia, or experienced one or more episodes of high blood sugar (hyperglycemia) with ketosis vs Gla-100 (6% vs 8.8% and 8.2% vs 11.4%, respectively).^[2]

The number of adverse events was comparable between the two treatment groups (65.2% vs 65.8% of patients reported any treatment-emergent adverse event).^[2] No unexpected safety concerns were reported, based on the established profiles of both products.^[2]

The study design includes a further 6-month safety follow-up period, which will be reported separately.^[2]

Job bag number: SAGB.TJO.19.12.2171                        Date of preparation: January 2020

References

[1] Sanofi. Summary of Product Characteristics (Toujeo). Available at: https://www.medicines.org.uk/emc/product/6938/smpc. Last accessed January 2020.

[2] Danne T et al., “Insulin Glargine 300 U/mL (Gla-300) provides effective glycemic control in youths with type 1 diabetes (T1D): the EDITION JUNIOR study”, Poster presentation P240, ISPAD 45th Annual Conference, Boston MA, U.S., October 31, 2019. Available at: http://www.professionalabstracts.com/ispad2019/Iplanner/#/presentation/216. Last accessed January 2020.

[3] Diabetes UK. Us, diabetes and a lot of facts and stats. Available online at: https://www.diabetes.org.uk/resources-s3/2019-02/1362B_Facts%20and%20stats%20Update%20Jan%202019_LOW%20RES_EXTERNAL.pdf  Last accessed January 2020.

[4] Patterson C et al, Trends and cyclical variation in the incidence of childhood type 1 diabetes in 26 European centres in the 25 year period 1989–2013: a multicentre prospective registration study. Diabetologia (2018) 62:3. Available online at: https://link.springer.com/article/10.1007%2Fs00125-018-4763-3. Last accessed January 2020.

[5] JDRF, Type 1 Diabetes Facts & Figures. Available online at: https://jdrf.org.uk/information-support/about-type-1-diabetes/facts-and-figures/. Last accessed January 2020.