FDA Grants Jardiance Expanded Indication

Label expansion includes treatment of cardiovascular disease in adult patients with type 2 diabetes.

The FDA has approved a new indication for Boehringer Ingelheim’s empagliflozin (Jardiance), allowing it to be used to reduce the risk of cardiovascular death in adult patients with type 2 diabetes (T2D) and cardiovascular disease (CVD).

The agency based its decision on the results of a postmarketing study it required when it initially approved Jardiance in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with T2D. In a clinical trial of more than 7000 patients with T2D and CVD, the use of Jardiance was found to reduce the risk of cardiovascular death compared with placebo when added to standard of care therapies for diabetes and atherosclerotic CVD.

Diabetic adults are 70% more likely to die from CVD than those without diabetes, according to the CDC.

“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, MD, CM, director of the FDA’s Division of Metabolism and Endocrinology Products, in a 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.”

The most common adverse events experienced by trial participants treated with Jardiance included urinary tract infections and female genital infections. The drug’s use has also been linked with dehydration, hypotension, ketoacidosis, serious urinary tract infection, acute kidney injury, renal function impairment, hypoglycemia when used with insulin or insulin secretagogues, genital mycotic infections, and increased cholesterol.

Additionally, Jardiance is not intended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The drug is contraindicated in patients with a history of serious hypersensitivity reactions to Jardiance, severe renal impairment, end-stage renal disease, or dialysis.