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The European Commission has approved an update to the Jardiance® (empagliflozin) label to include a change to the indication statement. Jardiance® is now indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise.The approved 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.Jardiance® is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date. Jardiance® is marketed by Boehringer Ingelheim and Eli Lilly and Company (LLY).
“One in two people with type 2 diabetes die of cardiovascular disease. The European Commission now reflects the importance of reducing cardiovascular death in these patients by extending the Jardiance label. This makes Jardiance the only diabetes drug which use is not restricted to just lowering blood glucose. That means that Jardiance enables physicians to provide their type 2 diabetes patient with established cardiovascular disease with a diabetes medication that can offer a life-saving cardiovascular benefit,” said Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim.
The updated EU label now includes results from the EMPA-REG OUTCOME® trial, which showed that Jardiance® reduced the risk of CV death by 38 percent versus placebo in patients with T2D and established CV disease when added to standard of care. The trial also 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. There were no statistically significant differences in the risk of non-fatal heart attack or non-fatal stroke
“This is very good news for the type 2 diabetes community,” said Enrique Conterno, Senior Vice President and President, Lilly Diabetes. “This approval from the European Commission, along with approvals from other regulatory authorities around the world, marks a significant step towards making a positive difference to the lives of people with type 2 diabetes and established cardiovascular disease.”
