Advertisement

Picture EBD Group BioPharm America 2017 BPA Boston MA Startup September 600x60px
Document › Details

Boehringer Ingelheim. (6/12/17). "Press Release: Empagliflozin (Jardiance) to Be Studied in Chronic Kidney Disease". Ingelheim & Indianapolis, IN.

Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 Eli Lilly & Co. Inc. (NYSE: LLY)
  Group Eli Lilly (Group)
Products Product Jardiance®
  Product 2 clinical research
Persons Person Woerle, Hans-Juergen (Boehringer 201706 Global VP Medicine)
  Person 2 Emmick, Jeff (Lilly 201706 VP Product Development at Lilly Diabetes)
     


> New outcome study to evaluate the effect of empagliflozin for the treatment of people with chronic kidney disease.

> Approximately 1 in 10 people worldwide are affected by chronic kidney disease.1,2

> The study is based on cardiovascular and renal results from the landmark EMPA-REG OUTCOME® trial.


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 (link is external).


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 (link is external).


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 (link is external) 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 LILLY DIABETES:

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


References

1. Levin, Adeera, et al. "Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy." The Lancet (2017).

2. Thomas, Bernadette, et al. "Global Cardiovascular and Renal Outcomes of Reduced GFR." Journal of the American Society of Nephrology (2017): ASN-2016050562.

3. Zinman B., et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 10.1056 (2015).

4. Wanner C, et al. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016;375:323-334.

5. Anders HJ, et al. Nephron Protection in Diabetic Kidney Disease. N Engl J Med 2016,375;21:2096-98

6. Cherney D, et al. Renal Hemodynamic Effect of Sodium-Glucose Cotransporter 2 Inhibition in Patients With Type 1 Diabetes Mellitus. Circulation 2014;129:587-597

7. United States Renal Data System, USRDS 2012 Annual data report: Atlas of chronic kidney disease and end-stage renal disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from: http://www.usrds.org/reference.htm. See Appendix I, United States Renal Data System (USRDS).

8. Liyanage T, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet.2015; 385(9981):1975-82.

9. Sarnak MJ, et al. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension. 2003;42:1050–1065.

10. Tonelli M, et al. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006;17:2034–2047.

11. Schiffrin EL, et al. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007;116:85–97.

12. https://www.usrds.org/2016/view/v1_01.aspx.

13. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney inter., Suppl. 2013; 3: 1–150.


Dr Petra Kienle
Media Contact - Metabolism
Media & PR
Phone +49 6132 77 143877
Fax +49 6132 77 6601
Binger Strasse 173
55216 Ingelheim am Rhein
GERMANY

   
Record changed: 2017-06-21

Advertisement

Picture EBD Group Bio-Europe 2017 BEU Berlin Germany November 600x60px

More documents for Boehringer Ingelheim (Group)


To subscribe to our free, monthly newsletter for the European life sciences, please send an e-mail to info@iito.de and simply fill the subject line with the word »LSE newsletter«

To get even more information, please take a look at our [gs] professional services offering and read the gene-sensor Product Flyer [PDF file]

Advertisement

Picture BIO Deutschland EBDC 2017 Heidelberg 600x60px




» top

Advertisements

Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px Picture EBD Group Bio-Europe 2017 BEU Berlin Germany November 120x80px Picture BIO Deutschland EBDC 2017 Heidelberg 120x240px Picture EBD Group BioPharm America 2017 BPA Boston MA Startup September 120x80px Picture [LSE] Life-Sciences-Europe.com – The Business Web Portal 120x600px Banner Fairtec GmbH Solutions for Smarter Business Events Exhibitions 120x120px Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px Picture BIO Deutschland EBDC 2017 Heidelberg 120x240px Picture EBD Group BioPharm America 2017 BPA Boston MA Startup September 120x80px Picture EBD Group Bio-Europe 2017 BEU Berlin Germany November 120x80px