The Food and Drug Administration (FDA) has approved an additional indication for Jardiance (empagliflozin; Boehringer Ingelheim and Lilly) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease.
This approval was based on a postmarketing study involving over 7,000 patients with T2DM and CV disease. The data showed empagliflozin significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14% over a median of 3.1 years when added to the standard of care vs. placebo. There was a 38% reduction in CV death with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The safety profile of empagliflozin was consistent with that of previous studies.
“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.”
In June 2016, the FDA’s Endocrinologic and Metabolic Drug Advisory Committee voted 12–11 that substantial evidence exists to support Jardiance for the reduction of cardiovascular death in adults with type 2 diabetes and established CV disease.
Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, was initially approved in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Jardiance is available in 10mg and 25mg strength tablets.
For more information visit FDA.gov.