FDA Approves Jardiance (Empagliflozin) to Treat Type 2 Diabetes Mellitus

August 1, 2014 - The FDA has approved Jardiance (empagliflozin) tablets in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc.

The use of Jardiance--a sodium glucose co-transporter 2 inhibitor--blocks the reabsorption of glucose by the kidneys, increasing glucose excretion and lowering the blood glucose level in patients with diabetes who have an elevated blood glucose level.

"Jardiance provides an additional treatment option for the care of patients with type 2 diabetes," said Curtis J. Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”

In 7 clinical trials involving 4480 patients with T2DM, the safety and effectiveness of Jardiance were evaluated. The trials showed that Jardiance improved glycated hemoglobin levels compared with placebo.

Jardiance has been studied as a stand-alone therapy and in combination with other T2DM therapies, including metformin, sulfonylureas, pioglitazone, and insulin.

Jardiance should not be used to treat individuals with type 1 diabetes mellitus, diabetic ketoacidosis, severe renal impairment, or end-stage renal disease, or in patients on dialysis.

The FDA is requiring 4 postmarketing studies for Jardiance:

• An ongoing cardiovascular outcomes trial
• A pediatric pharmacokinetic/pharmacodynamic study
• A pediatric safety and efficacy study, in which the effect on bone health and development will be evaluated
• A nonclinical (animal) juvenile toxicity study with a focus on renal development, bone development, and growth