U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure

RIDGEFIELD, Conn. and INDIANAPOLIS - The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced. The Fast Track designation facilitates the development of new therapies that fill an unmet medical need for serious conditions in an effort to expedite the availability of new treatment options.

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:

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.

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.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

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.comand newsroom.lilly.com/social-channels.