Jardiance^® (empagliflozin) receives approval in the EU for the treatment of type 2 diabetes in children aged 10 years and above

• Following approval by the U.S. Food and Drug Administration (FDA) in June 2023,^2,3 the EC approval adds another important treatment option to the standard of care in the EU for children aged 10 years and above living with T2D.¹
• Empagliflozin is the first sodium-glucose co-transporter-2 (SGLT2) inhibitor to demonstrate a statistically significant reduction in the primary outcome of HbA1c (hemoglobin A1C test which measures average blood sugar) in participants aged 10-17 years living with T2D compared to placebo.^₄
• Safety data in this vulnerable population was similar to that in adults with T2D, with the exception of hypoglycemic risk, which was higher in the pediatric patients treated with empagliflozin compared to placebo regardless of concomitant insulin use.⁴

Why it matters

• T2D in young people is a global public health issue with 41,600 children and adolescents worldwide affected each year.^5,6 Over the course of the past thirty years, global rates of T2D in adolescents and young adults has increased by 56%.⁷
• The ever-increasing rates of T2D in children and adolescents presents a growing burden on healthcare systems in Europe, where T2D care costs around $189 million every year. There is a need for additional clinically beneficial treatment options.⁶
• Diabetes can be linked to serious medical conditions. Young people with T2D are more likely to have or develop other cardiovascular, renal, and metabolic conditions (e.g. high blood pressure, elevated triglycerides and obesity).⁶

Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim:

“Type 2 diabetes (T2D) is a growing health challenge worldwide, particularly among young people. The recent approval of empagliflozin expands access to a trusted treatment option in the EU, providing hope to an underserved community. This decision by the European Commission demonstrates our unwavering dedication to innovative solutions that improve the well-being of people with interconnected cardio-renal-metabolic conditions like T2D. Together, we strive to combat this pressing health issue and improve health outcomes across Europe.”

Leonard Glass, M.D., F.A.C.E., Senior Vice President, Diabetes & Obesity Global Medical Affairs, Lilly & Company:

“With rates of T2D continuing to increase in young people and the high-risk of serious medical conditions as a complication of this disease, timely interventions with innovative solutions are essential. With the approval of empagliflozin for children aged 10 years and above with T2D in the EU, we now have a new oral treatment option for this vulnerable population.”

Contact:

Kristiane Bello
Lilly Diabetes Communications
Eli Lilly and Company
Email: bello_kristiane@lilly.com

Boehringer Ingelheim and Eli Lilly and Company

The Boehringer Ingelheim and Lilly Alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate their commitment, not only to the care of people with type 2 diabetes, but also to address areas of unmet medical need like heart failure and chronic kidney disease.

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com. 

About Lilly

Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit lilly.com and lilly.com/newsroom or follow us on Facebook, Instagram, X (Twitter) and LinkedIn.

References

¹Data on file.

²Boehringer Ingelheim. US FDA approves Jardiance^® (empagliflozin) for the treatment of type 2 diabetes in children 10 years and older. June 2023. Available at: https://www.boehringer-ingelheim.com/us/press-releases. Accessed December 2023.

³Lilly. Phase III trial demonstrated Jardiance^® is the first SGLT2 inhibitor to show statistically significant reduction in blood sugar levels in children and adolescents with type 2 diabetes. Available at: https://investor.lilly.com/news-releases/news-release-details/phase-iii-trial-demonstrated-jardiancer-first-sglt2-inhibitor. Accessed December 2023.

⁴Laffel LM, Danne T, Klingensmith GJ, et al. Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial. Lancet Diabetes Endocrinol. 2023;11: 169-191. https://doi.org/10.1016/S2213-8587(22)00387-4 

⁵Wu H, Patterson C, Zhang X, et al. Worldwide estimates of incidence of type 2 diabetes in children and adolescents in 2021. Diabetes Res Clin Pract. 2022; 185:109785. doi: 10.1016/j.diabres.2022.109785.

⁶International Diabetes Federation. IDF Diabetes Atlas. 10^th Edition. 2021. Available at: https://diabetesatlas.org/idfawp/resource-files/2021/07/IDF_Atlas_10th_Edition_2021.pdf. Accessed: December 2023.

⁷British Medical Journal. Substantial Rise in type 2 diabetes among young people. Available at: https://www.bmj.com/company/newsroom/substantial-rise-in-type-2-diabetes-among-young-people/#:~:text=The%20results%20show%20that%20the,150%20per%20100%2C000%20in%202019. Accessed: December 2023.