Boehringer Ingelheim and Eli Lilly Diabetes Alliance Restructures to Focus Exclusively on Jardiance® (Empagliflozin)

Ingelheim, Germany, November 5, 2019 /PRNewswire/ -- To better serve patients, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) will adjust their existing alliance effective January 1, 2020, focusing their combined expertise and investments on the continued development and commercialization of Jardiance® (empagliflozin) for patients with type 2 diabetes, heart failure, and chronic kidney disease. Trajenta® (linagliptin) and Basaglar® (insulin glargine) will remain part of the alliance, with marketing primarily led by their respective developing companies. Boehringer Ingelheim will continue to lead the marketing of Trajenta®, while Eli Lilly will continue to lead the marketing of Basaglar®.

Carine Brouillon, Global Therapeutic Area Head at Boehringer Ingelheim, stated, “Since its establishment in 2011, the alliance has achieved tremendous success, with Jardiance®, Trajenta®, and Basaglar® becoming strong brands that continue to grow steadily within their respective categories globally. As the potential of SGLT2 inhibitors in treating a broad range of conditions continues to be realized, concentrating our expertise and resources to support this important therapeutic approach will not only create greater value for both companies but also better serve more patients with type 2 diabetes as well as those without type 2 diabetes.”

Jardiance® is the most prescribed SGLT2 inhibitor in many markets worldwide, including the United States. It is also the first oral antidiabetic medication proven to significantly reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Furthermore, due to its well-established cardiovascular benefits, empagliflozin is recommended by more than 60 guidelines globally for the treatment of patients with type 2 diabetes and comorbid cardiovascular disease. Experts from the American College of Cardiology (ACC) unanimously agree that empagliflozin is the preferred SGLT2 inhibitor, as it has been demonstrated to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and coexisting cardiovascular disease.^[1]

Mike Mason, Senior Vice President of Connected Care and Insulin at Eli Lilly, stated, “Building on the EMPA-REG OUTCOME® study, several pivotal clinical trials are underway to evaluate the safety and efficacy of Jardiance® in patients with heart failure or chronic kidney disease. The study populations include both patients with type 2 diabetes and those without type 2 diabetes. The results of these trials will help us understand how to further improve the quality of life for these patient populations. Jardiance® has a bright future, and the alliance is committed to doing everything possible to ensure its success.” Mr. Mason will assume the role of President of Eli Lilly’s Global Diabetes Division effective January 1, 2020.

On Diabetes and Cardiovascular Disease

There are over 425 million people with diabetes worldwide, of whom approximately 212 million remain undiagnosed.^[2]By 2045, the global number of people with diabetes is projected to rise to 629 million. ^[2]Type 2 diabetes is the most common form of diabetes, accounting for up to 90% of all cases in high-income countries. Diabetes is a chronic disease that occurs when the body cannot properly produce or utilize insulin.^[3]

Given diabetes-related comorbidities such as hyperglycemia, hypertension, and obesity, cardiovascular disease is the most common complication of diabetes and the leading cause of death.^[3],[4] Individuals with diabetes are two to four times more likely to develop cardiovascular disease than those without diabetes.^[5],[6] In 2017, diabetes caused 4 million deaths worldwide, with cardiovascular disease being the leading cause.^[2]Approximately 50% of deaths among patients with type 2 diabetes worldwide are caused by cardiovascular disease.^[7],[8]

Compared with their non-diabetic peers, 60-year-old patients with diabetes may have a life expectancy shortened by up to 6 years. For 60-year-old diabetic patients with a prior history of myocardial infarction or stroke, life expectancy may be reduced by up to 12 years compared with age-matched individuals without such conditions.^[9]

Since 2016, more than 60 treatment guidelines worldwide have been updated, reflecting the recognition of diabetes medications with proven cardiovascular benefits. These include the consensus report issued by the American Diabetes Association and the European Association for the Study of Diabetes, which recommends the use of SGLT-2 inhibitors (such as empagliflozin) or GLP-1 receptor agonists with cardiovascular benefits as part of glycemic management in patients with type 2 diabetes and atherosclerotic cardiovascular disease.^[10]

About Empagliflozin

Empagliflozin (brand name Jardiance®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medication whose labeling in many countries includes data on reducing the risk of cardiovascular death.^{[11],[12],[13]}

Empagliflozin helps patients with type 2 diabetes and hyperglycemia excrete excess glucose in the urine by inhibiting SGLT2. Furthermore, the use of empagliflozin increases sodium excretion from the body and reduces fluid load on the vascular system (i.e., intravascular volume). Data from the EMPA-REG OUTCOME® trial demonstrate that empagliflozin induces changes in the metabolism of glucose, sodium, and water, thereby reducing the risk of cardiovascular death.

[1] Das SR, Evertt BM, Birtcher KK, et al. 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. 2018;72(24):3200-23

[2] International Diabetes Foundation. Diabetes Atlas 8th Edition. Available at: https://diabetesatlas.org/resources/2017-atlas.html. Accessed: September 2019.

[3] World Health Organisation. Diabetes: Fact Sheet no. 312. Available at: www.who.int/mediacentre/factsheets/fs312/en/#. Accessed: August 2019.

[4] World Heart Federation. Diabetes as a Risk Factor for Cardiovascular Disease. Available at: www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes. Accessed: September 2019.

[5] Beckman J, Creager M, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002;287:2570-81.

[6] Di Angelantonio E, Kaptoge S ,Wormser D, et al. The Emerging Risk Factors Collaboration: Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314:52-60

[7] Morrish NJ, Wang SL, Stevens LK, et al. Mortality and Causes of Death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(2):S14-21.

[8] Einarson TR, Acs A, Ludwig C, et al. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007–2017. Cardiovasc Diabetol. 2018;17:83.

[9] The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.

[10] Davies MJ, D’Alessio DA, Fradkin J, et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41(12):2669-2701.

[11] Jardiance® (empagliflozin) tablets. U.S. Prescribing Information, approved October 2018.

[12] Jardiance® (empagliflozin) tablets. European Summary of Product Characteristics, approved February 2019.

[13] Jardianz® (empagliflozin) tablets. Mexican Full Prescribing Information, approved August 2017.