CHMP issues positive opinion to expand Jardiance®, Synjardy® and Glyxambi® labels to include positive effects on cardiovascular and renal outcomes

INGELHEIM, Germany & INDIANAPOLIS–(BUSINESS WIRE)–

• European labels for Jardiance^®, Synjardy^® and Glyxambi^® expanded to include positive effects on cardiovascular and renal endpoints from landmark EMPA-REG OUTCOME^® trial¹

Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the labels of Jardiance^® (empagliflozin), Synjardy^® (empagliflozin and metformin) and Glyxambi^® (empagliflozin and linagliptin) to include additional important data from the landmark EMPA-REG OUTCOME^® trial on heart failure and kidney endpoints.^1,2,3,4

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The labels now include additional results from the EMPA-REG OUTCOME^® trial, specifically a relative risk reduction in hospitalisation for heart failure by 35 percent and a relative risk reduction for new-onset or worsening of kidney disease by 39 percent with empagliflozin, compared with placebo, in people with type 2 diabetes and established cardiovascular disease.^1,2,3,4,5

“Heart failure and kidney disease are highly prevalent in people with type 2 diabetes and are associated with high morbidity and mortality,” commented Dr Waheed Jamal, Corporate Vice President, Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Due to the current unmet medical need to treat these conditions, we are pleased that the European Medicines Agency has recognised the demonstrated benefits of empagliflozin to reduce the risks of heart failure and kidney disease in people with type 2 diabetes and established cardiovascular disease.”

“In the EMPA-REG OUTCOME^® trial, empagliflozin demonstrated superiority in reducing the risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly Diabetes. “As a result, empagliflozin was the first type 2 diabetes treatment to have either a cardiovascular indication or data on the reduction of the risk of cardiovascular death included in the label.”

Based on results from the EMPA-REG OUTCOME^® trial, Boehringer Ingelheim and Eli Lilly and Company are further investigating empagliflozin in people with heart failure (EMPEROR and EMPERIAL clinical trials) and chronic kidney disease (EMPA-KIDNEY clinical trial), both with and without diabetes.^6,7,8,9

About EMPA-REG OUTCOME^®4,5

EMPA-REG OUTCOME^® is a long-term, multinational, randomised, double-blind, placebo-controlled clinical trial of more than 7,000 people from 42 countries with type 2 diabetes and established cardiovascular disease.

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.

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

About Heart Failure

Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body.¹⁰ Symptoms of heart failure include difficulty breathing, swelling, and fatigue amongst others.¹¹ Heart failure is a prevalent disease; 26 million people around the world have chronic heart failure.¹² 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.¹³ Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the United States and Europe.¹² Heart failure is highly prevalent in people with diabetes;¹⁴ however, approximately half of all people with heart failure do not have diabetes.^12,15

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 conditions such as diabetes, obesity and hypertension.^16,17,18

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 kidney disease.^19,20,21 Once end stage kidney disease is reached, affected individuals have to undergo kidney replacement treatments, such as chronic dialysis or kidney transplantation.²² Chronic kidney disease is highly prevalent in various parts of the world, affecting more than 10 percent of the population.²³ Since there is currently no approved treatment available to specifically reduce kidney disease progression and cardiovascular death, the overarching unmet medical need for new treatment options in people with chronic kidney disease is evident.

About Empagliflozin

Empagliflozin (marketed as Jardiance^®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include data on the reduction of the risk of cardiovascular death in the label.^24,25,26

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 and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME^® trial.

Please click on the following link for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/press-release/chmp-positive-opinion

View source version on businesswire.com: https://www.businesswire.com/news/home/20180702005331/en/

Contacts

Dr Petra Kienle
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Grant Smith
Manager, Global Business Communications
Eli Lilly and Company
Email: grant.smith@lilly.com
Phone: +1 (317) 954-9907