Jardiance® (empagliflozin) becomes first type 2 diabetes medicine in the EU to include cardiovascular death reduction data in label

The European Commission has approved an update to the Jardiance^® (empagliflozin) label to include a change to the indication statement. Jardiance^® is now indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise. The approved product information now includes data on the reduction of risk of cardiovascular (CV) death in patients with T2D and established CV disease in addition to data on the improvement of blood sugar control. Jardiance^® is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date. Jardiance^® is marketed by Boehringer Ingelheim and Eli Lilly and Company (LLY).

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“One in two people with type 2 diabetes die of cardiovascular disease. The European Commission now reflects the importance of reducing cardiovascular death in these patients by extending the Jardiance label. This makes Jardiance the only diabetes drug which use is not restricted to just lowering blood glucose. That means that Jardiance enables physicians to provide their type 2 diabetes patient with established cardiovascular disease with a diabetes medication that can offer a life-saving cardiovascular benefit,” said Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim.

The updated EU label now includes results from the EMPA-REG OUTCOME^® trial, which showed that Jardiance^® reduced the risk of CV death by 38 percent versus placebo in patients with T2D and established CV disease when added to standard of care. The trial also demonstrated that Jardiance^® significantly reduced the risk of the primary endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo when added to standard of care in adults with T2D and established CV disease. There were no statistically significant differences in the risk of non-fatal heart attack or non-fatal stroke.

“This is very good news for the type 2 diabetes community,” said Enrique Conterno, Senior Vice President and President, Lilly Diabetes. “This approval from the European Commission, along with approvals from other regulatory authorities around the world, marks a significant step towards making a positive difference to the lives of people with type 2 diabetes and established cardiovascular disease.”

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About the EMPA-REG OUTCOME ^® Trial

EMPA-REG OUTCOME^® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with T2D and established CV disease.

The study assessed the effect of Jardiance^® (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 sugar-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.

Over a median of 3.1 years, Jardiance^® significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. The risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.

The overall safety profile of Jardiance^® in the EMPA-REG OUTCOME^® trial was consistent with that of previous trials.

About Diabetes and Cardiovascular Disease

More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed. By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide. T2D is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, CV disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop CV disease than people without diabetes. In 2015, diabetes caused 5 million deaths worldwide, with CV disease as the leading cause. Approximately 50 percent of deaths in people with T2D worldwide are caused by CV disease.

About Jardiance ^®

Jardiance^® (empagliflozin) is an oral, once daily, highly selective sodium-glucose co-transporter-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 Jardiance^® (empagliflozin) in patients with T2D and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of Jardiance^® 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). Excretion of sugar, salt and water after the initiation of treatment with empagliflozin may therefore contribute to the improvement in cardiovascular outcomes.

The change to the existing indication approved by the European Commission is as follows:

Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

• as monotherapy when metformin is considered inappropriate due to intolerance
• in addition to other medicinal products for the treatment of diabetes

For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Jardiance^® is not approved for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).

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. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

Boehringer Ingelheim

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates presently with a total of some 50,000 employees worldwide. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.

For more information please visit www.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 or follow @LillyDiabetes.

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.

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.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about JARDIANCE as a treatment for adults with type 2 diabetes and established CV 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 JARDIANCE 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.

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Contact information

Boehringer Ingelheim
Dr Petra Kienle
Product Communication Manager
Email: petra.kienle@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Lilly Diabetes
Molly McCully
Communications Manager
Email: mccully_molly@lilly.com
Phone: +1 (317) 478 5423