Jardiance will be used to treat patients with type 2 diabetes mellitus. | Courtesy of Shutterstock
+ Regulatory
Jeff Gantt | Dec 9, 2016

FDA approves Jardiance for reduction of cardiovascular death

The U.S. Food and Drug Administration has approved of a new indication of Jardiance (empagliflozin) for the reduction of cardiovascular death risk in adult patients who have type 2 diabetes mellitus and cardiovascular disease.

“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology Products Director Jean-Marc Guettier said. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”

Death caused by cardiovascular disease is 70 percent higher in adults who have diabetes in comparison to adults who do not have the disease, according to the Centers for Disease Control and Prevention (CDC).

Furthermore, the CDC stated that patients who have diabetes also have a reduced life expectancy due to premature cardiovascular death.

The FDA approved Jardiance due to a study that was required by the agency when the treatment was first approved in 2014 as an additive to diet and exercise to help in the improvement of glycemic control in adults who have type 2 diabetes mellitus.

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