June 28, 2019 PR-M06-19-NI-058
This designation is for the ongoing EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will evaluate the effect of empagliflozin on cardiovascular death and hospitalization for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction, respectively.
“Heart failure contributes to one in nine deaths and is a leading cause of hospitalization in the U.S., yet there are limited treatment options for people living with this debilitating disease,” said Mohamed Eid, M.D., M.P.H., M.H.A, vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “The FDA Fast Track designation for empagliflozin is an important step forward in addressing this unmet need, and we look forward to working closely with the FDA as we explore the potential for empagliflozin to improve outcomes for adults with chronic heart failure.”
Heart failure is a serious condition in which the heart is unable to supply enough blood to the body. About half of people who develop heart failure die within five years. Heart failure also leads to a substantial reduction in quality of life and a high symptom burden, in part due to limitation of physical activity and difficulty carrying out typical everyday activities. Already affecting 26 million people worldwide, including more than 6.5 million in the U.S., heart failure is expected to become even more prevalent.
“Boehringer Ingelheim and Lilly are committed to advancing treatments that address the public health challenges of cardiometabolic diseases, including chronic heart failure,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “We eagerly anticipate results from the EMPEROR studies as we advance the development of empagliflozin in this setting.”
The two EMPEROR phase III studies include more than 8,500 people with chronic heart failure and are designed to assess the effect of treatment with empagliflozin on cardiovascular death and hospitalization for chronic heart failure as primary endpoints. The EMPEROR studies are part of the empagliflozin chronic heart failure program.
Empagliflozin, marketed as Jardiance® in the U.S., is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
About the Empagliflozin Chronic Heart Failure Program
The empagliflozin chronic heart failure program consists of the EMPEROR-Reduced and EMPEROR-Preserved studies, the EMPERIAL-Reduced and EMPERIAL-Preserved studies and the EMPA-VISION study. These studies are evaluating the efficacy and safety of empagliflozin in more than 9,000 adults with chronic heart failure, including those with and without diabetes.
About the EMPEROR Chronic Heart Failure Studies
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies are two phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with chronic heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
*Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood.
HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.
HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared with a normally functioning heart.
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply enough blood around the body. Symptoms of heart failure include difficulty breathing, swelling – most commonly in feet, legs and ankles – and fatigue, among others. Heart failure also leads to a substantial reduction in quality of life, due in part to difficulty carrying out typical everyday activities.
Affecting 26 million people worldwide, the prevalence of heart failure is expected to increase as the population ages. While heart failure is very common in people with diabetes, approximately half of people with heart failure do not have diabetes.
There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the U.S. and Europe.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
IMPORTANT SAFETY INFORMATION
Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
Do not take JARDIANCE if you have severe kidney problems or are on dialysis.
JARDIANCE can cause serious side effects, including:
You may be at a higher risk of dehydration if you:
If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away.
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.
These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.
Before taking JARDIANCE, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch(link is external) or call 1-800-FDA-1088.
For more information, please see Prescribing Information and Medication Guide.
CL-JAR-100026 10.30.18
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers 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(link is external).
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned, and today our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients’ lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.
In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.
Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.
For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
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).
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 for chronic heart failure and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug 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 a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
Jardiance® is a registered trademark of Boehringer Ingelheim.
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