U.S. FDA approves Jardiance® for treatment of adults with chronic kidney disease

Ingelheim, Germany, and Indianapolis, U.S., Thu, 09/21/2023 - 14:00

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) have received approval from the U.S. Food and Drug Administration (FDA) for Jardiance^®(empagliflozin) 10mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression¹.

Following the recent approval by the European Commission², the FDA approval adds an important treatment option to the standard of care for the more than 35 million adults in the U.S. affected by CKD³.
Approval in CKD adds to existing indications in type 2 diabetes and heart failure; these interconnected conditions affect over 1 billion people worldwide⁵.
Decision is based on the results from the landmark phase III EMPA-KIDNEY trial, the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date^6,7.

Why does this matter?

CKD affects 850 million people worldwide, which is more than 10 percent of the population⁸. This includes the more than 35 million adults in the U.S affected by CKD³.
Disease progression often leads to serious outcomes such as dialysis and transplantation, or cardiovascular death⁹. Hospitalizations for CKD account for a third to a half of total healthcare costs in the U.S.¹⁰, and the condition is often interconnected with diseases of the heart and metabolic system such as heart failure or type 2 diabetes⁵.

Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim:

“CKD is a global health crisis and often called a silent epidemic, resulting in a huge need for raising awareness and having additional treatment options. The FDA approval in CKD marks a crucial milestone in our mission to expedite access to empagliflozin for people living with interconnected cardio-renal-metabolic conditions.”

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

“Following previous indications for empagliflozin in heart failure and type 2 diabetes, this FDA approval now provides physicians, including nephrologists, with an important treatment option for people living with CKD. Alongside the recent CKD approval for empagliflozin in the EU, this decision further bolsters our efforts to support this community globally.”

Contacts:

Harro Ten Wolde
Boehringer Ingelheim Corporate Affairs
Email: harro.ten_wolde@boehringer-ingelheim.com

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, Twitter and LinkedIn.

References

¹Data on file.

²European Commission. Jardiance. Union Register of medicinal products for human use. Available at: https://ec.europa.eu/health/documents/community-register/html/h930.htm. Accessed: September 2023.

³Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2023 FactSheet. Available at: https://www.cdc.gov/kidneydisease/pdf/CKD-Factsheet-H.pdf. Accessed: September 2023.

⁴EMC. Jardiance 10 mg film-coated tablets. Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/5441/smpc#gref. Accessed: September 2023.

⁵Schechter, M. et al. Cardiovasc Diabetol. 2022:21;104.

⁶EMPA-KIDNEY full data presentation, presented on 4 November 2022 at the American Society of Nephrology (ASN) Congress 2022 - Kidney Week.

⁷Herrington W, Staplin N, Wanner C, et al. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023; 388:117-127.

⁸Li P, et al. Braz J Med Biol Res. 2020; 53(3): e9614.

⁹National Kidney Federation. Chronic kidney disease (CKD). Available at: https://www.kidney.org/atoz/content/about-chronic-kidney-disease. Accessed: September 2023.

¹⁰Nichols, G. et al. J Am Soc Nephrol. 2020 Jul;31(7):1594-1601.