FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes
There are many types of medications used for managing blood glucose in people with type 2 diabetes. However, none of the available medications have been shown in long-term studies to reduce the risk of death from cardiovascular events. A newer glucose lowering agent, empagliflozin (Jardiance), is the first anti-diabetic drug to show a reduction in death due to cardiovascular events; on December 2, 2016, the US Food and Drug Administration approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “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.”
According to the Centers for Disease Control and Prevention, death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature cardiovascular death.
The FDA’s decision is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Jardiance was studied in a postmarket clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.
Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
Learn more about Jardiance.
Food And Drug Administration, Posted December 2, 2016