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U.S. FDA approves Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease

6.12.2016 07:00 | Business Wire

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The U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Jardiance® is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit. Jardiance® is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY).

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161205006066/en/

“As the only diabetes treatment approved by the FDA to reduce the risk of cardiovascular death, Jardiance® represents a tremendous step forward in our efforts to reduce the impact of heart disease among adults with type 2 diabetes and cardiovascular disease,” said Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “This approval is another example of our commitment to the discovery and development of treatment options for adults with type 2 diabetes. We believe that Jardiance® is an important treatment option for this patient population.”

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

The approval is based on breakthrough evidence from the landmark EMPA-REG OUTCOME® trial, which investigated the effects of Jardiance® compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. In the trial, Jardiance® significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo (HR 0.86, 95% CI: 0.74-0.99); absolute risk reduction was 1.6 percent for Jardiance® versus placebo. This primary finding was driven by a significant 38 percent reduction in the risk of cardiovascular death (HR 0.62, 95% CI: 0.49-0.77); absolute risk reduction was 2.2 percent for patients taking Jardiance® versus placebo. There was no change in the risk of non-fatal heart attack (HR 0.87, 95% CI: 0.70-1.09) or non-fatal stroke (HR 1.24, 95% CI: 0.92-1.67). The cardiovascular benefits of Jardiance® were consistent among patient subgroups.

Adults with type 2 diabetes should not take Jardiance® if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in Jardiance®. Jardiance® can cause dehydration and low blood pressure. Jardiance® can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose when used with insulin or insulin secretagogues (e.g., sulfonylurea, a medication used to treat type 2 diabetes), vaginal yeast infections and yeast infections of the penis, and increased cholesterol.

“People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. The new indication for empagliflozin enables physicians for the first time to provide adults with type 2 diabetes with a diabetes medication that can reduce their risk of dying from cardiovascular disease,” said Professor Christopher P. Cannon, M.D., Cardiovascular Division, Brigham and Women's Hospital and professor of medicine, Harvard Medical School. “It also gives physicians an opportunity to speak with and educate people with type 2 diabetes about their increased risk for cardiovascular disease and to help them understand this serious complication of their condition.”

“Despite significant medical advances, approximately two out of three people with type 2 diabetes in the US still die from cardiovascular disease. The Boehringer Ingelheim and Lilly Diabetes Alliance is proud to bring a groundbreaking innovation to millions of adults with type 2 diabetes and established cardiovascular disease,” said Enrique Conterno, Senior Vice President and President, Lilly Diabetes. “As part of our ongoing commitment to people with type 2 diabetes, we are also expanding our efforts to educate the public on the link between cardiovascular disease and type 2 diabetes.”

In 2014, Jardiance® was approved by the FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes.

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About the EMPA-REG OUTCOME ® Trial (NCT01131676)

EMPA-REG OUTCOME® was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes and established cardiovascular 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 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.

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

The safety profile of Jardiance® in the EMPA-REG OUTCOME® trial was consistent with that of previous trials. The overall incidence of adverse events was similar to placebo.

About Diabetes and Cardiovascular Disease

Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 percent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body 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, cardiovascular 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 cardiovascular disease than people without diabetes. Approximately 50 percent of deaths in people with type 2 diabetes worldwide and 68 percent of deaths in people with type 2 diabetes in the U.S. are caused by cardiovascular disease. In the U.S., health care costs for managing cardiovascular conditions in patients with diabetes totaled more than $23 billion in 2012.

Having diabetes can shorten a person’s lifespan by as much as six years compared with someone without diabetes.* And having both diabetes and a history of heart attack or stroke can shorten a person’s lifespan by as much as 12 years compared with someone without these conditions.**

* Based on having a history of diabetes at age 60.

** Based on having a history of diabetes and heart attack or stroke at age 60.

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.

Jardiance® works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.

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

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.

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Please click on the link below for ‘Notes to Editors’ and ‘References’:

https://www.boehringer-ingelheim.com/press-release/fda-approval-jardiance-cv-label

Contact information

Boehringer Ingelheim
Dr Petra Kienle
Product Communications 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

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