INGELHEIM, Germany & INDIANAPOLIS--(BUSINESS WIRE)--The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today adopted a positive opinion to update the Jardiance® (empagliflozin) label including a change to the indication statement. The CHMP recommends Jardiance® for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise. The recommended 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 in patients with T2D. Jardiance® is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date.
The positive opinion is based on results from the EMPA-REG OUTCOME® trial. The trial 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. Taking Jardiance® on top of standard of care reduced the risk of dying from CV disease by 38 percent. There were no statistically significant differences in the risk of non-fatal heart attack or non-fatal stroke.
“Cardiovascular disease is the number one cause of death among people with type 2 diabetes. The life expectancy of people with type 2 diabetes and cardiovascular disease is up to 12 years shorter. There is a significant need for therapies which add to and go beyond the current standard of care,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim. “Therefore, this recommendation by the CHMP is an important step towards addressing and reducing the burden of cardiovascular mortality for people with type 2 diabetes.”
On December 2, the U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® to reduce the risk of CV death in adults with T2D and established CV 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 T2D.
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 CV outcomes.
The change to the existing indication adopted by the CHMP 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 CV 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).
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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