Empagliflozin (Jardiance^®) to be studied in chronic kidney disease

Ingelheim, Germany and Indianapolis, US, 12 June, 2017 – Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced to conduct a new, large clinical outcomes trial investigating empagliflozin for the treatment of people with chronic kidney disease. The trial is planned to enroll approximately 5,000 people with chronic kidney disease both with and without type 2 diabetes.

“Our plans for this new trial are yet another example of our ongoing commitment to improving patient health, especially in areas where unmet needs exist,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim. “We look forward to exploring the potential that empagliflozin may offer for people with chronic kidney disease.”

Jardiance^® (empagliflozin) is the first type 2 diabetes medicine to have data on the reduction of the risk of cardiovascular death included in the label in several countries. The EMPA-REG OUTCOME^® trial demonstrated that empagliflozin reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). As one of the secondary endpoints this trial also showed that empagliflozin reduced the relative risk for new-onset or worsening of kidney disease by 39 percent versus placebo.^3,4 Based on these results the Boehringer Ingelheim and Lilly Diabetes Alliance decided to formally investigate the potential of empagliflozin in people with chronic kidney disease. This outcome trial together with ongoing mechanistic studies will allow us to further explore the potential mechanisms - including the reduction in glomerular pressure - by which empagliflozin may impact renal outcomes in chronic kidney disease.^5,6

“More than 10 percent of people worldwide are affected by chronic kidney disease. Its prevalence and severity markedly influence the prognosis and quality of life of patients,” said Professor Christoph Wanner, Chief of the Division of Nephrology and Hypertension at the University Hospital of Wuerzburg, Germany. “New treatments that may have the potential to help address this crucial medical need are desperately needed.”

“Based on the cardiovascular and renal results of the EMPA-REG OUTCOME trial, we along with Boehringer Ingelheim look forward to starting this new trial to gather evidence in support of a potential new indication for empagliflozin in people with chronic kidney disease," said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly Diabetes.

About chronic kidney disease 
Chronic kidney disease is defined as a progressive decline of kidney function over time.  
About two thirds of chronic kidney disease cases are attributable to metabolic diseases such as diabetes, hypertension and obesity.^1,7,8 
Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage renal disease.^9,10,11,12 Chronic kidney disease is highly prevalent in various parts of the world, affecting approx. 10-15% of the population. Since there are currently only few treatment options, the overarching unmet medical need for new treatment options in chronic kidney disease is evident.¹³

About Empagliflozin
Empagliflozin (marketed as Jardiance^®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body (i.e. sodium) and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). 

Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

About EMPA-REG OUTCOME^{® 3,4}
EMPA-REG OUTCOME^® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 people from 42 countries with type 2 diabetes at high risk for cardiovascular events.

The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

Although the EMPA-REG OUTCOME^® trial was not designed to assess the potential mechanisms behind the effect of empagliflozin on kidney outcomes, the kidney assessment was part of a pre-specified exploratory analysis plan of additional endpoints. 

The overall safety profile of empagliflozin was consistent with that of previous trials. 

Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

Boehringer Ingelheim and Eli Lilly and Company 
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

Boehringer Ingelheim 
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. 
In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. 

More information about Boehringer Ingelheim can be found on http://www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.

About Eli Lilly and Company 
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. 

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about empagliflozin as a potential treatment of people with chronic kidney disease, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

CONTACT:

Dr Petra Kienle
Product Communication Manager
Boehringer Ingelheim 
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877

Grant Smith
Communications 
Lilly Diabetes
Email: grant.smith@lilly.com
Phone: +1 (317) 954 9907