FDA: Jardiance Approved to Reduce Cardiovascular Death Risk
FDA approves new indication for Jardiance.
Adults with type 2 diabetes can now be prescribed Jardiance® (empagliflozin, Boehringer Ingelheim) to reduce the risk for cardiovascular (CV) death, according to a press release from the US Food and Drug Administration (FDA).
The decision to approve the new indication was based on a postmarketing study in which researchers assessed more than 7000 patients with both type 2 diabetes and cardiovascular disease (CVD). Compared with placebo, risk for CV death was reduced with Jardiance® when added to standard of care for diabetes and atherosclerotic cardiovascular disease (ASCVD), according to the study results.
The FDA required the postmarketing study in 2014 when the drug was initially approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes,” Jean-Marc Guettier, MD, CM, director of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research, said in an agency press release. “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.”
Jardiance® is not intended for patients with type 1 diabetes, and is contraindicated in patients with a history of severe renal impairment, end-stage renal disease, or dialysis. The most commonly experienced side effects are urinary tract and female genital infections.
- FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes [news release]. Silver Springs, MD: US Food and Drug Administration. Published December 2, 2016. Accessed December 2, 2016.