U.S. FDA approves Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease
Mumbai, December 7th, 2016: 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®, marketed by Boehringer Ingelheim 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.
“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).
“Globally the prevalence of type 2 diabetes is high and is reaching alarming proportions in many countries especially India. With the U.S. FDA approval, Jardiance is a proven option for reducing cardiovascular mortality in adult patients of type-2 diabetes, having cardiovascular disease. This breakthrough approval from the U.S. FDA shows our commitment towards providing novel and innovative treatment options for diabetes management.” said Mr. Sharad Tyagi, Managing Director, Boehringer Ingelheim India.
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 therapies in adult patients of type 2 diabetes and established cardiovascular disease. In the trial, Jardiance® demonstrated 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 significant change in the risk of ‘non-fatal’ heart attack or ‘non-fatal’ stroke. The cardiovascular benefits of Jardiance® were consistent among the 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.”
In 2014, Jardiance® was approved by the U.S.FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes. In India, Jardiance is currently approved for use an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
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