FDA Approves Jardiance (empagliflozin) for Adults with Type 2 Diabetes

In 2014, the FDA announced the approval of Jardiance (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.1,2

The safety and efficacy of Jardiance were studied in a total of 7 clinical trials with 4,480 patients with type 2 diabetes. Results of the pivotal trials showed that Jardiance improved hemoglobin A1c levels compared with placebo. The most commonly occurring adverse events in clinical trials were urinary tract infections and female genital infections. One potential side effect of Jardiance is dehydration, which can cause a drop in blood pressure, resulting in dizziness and/or fainting and a decline in renal function. This was more apparent in elderly patients, patients with impaired renal function, and patients on diuretics to treat other conditions. Jardiance has been studied as a monotherapy therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylureas, pioglitazone, and insulin.

Although Jardiance received approval from the FDA, the agency is requiring that 4 additional postmarketing studies be conducted. These include:

  • Completion of an ongoing cardiovascular outcomes trial
  • A pediatric pharmacokinetic/pharmacodynamic study
  • A pediatric safety and efficacy study, including evaluation of the effect on bone health and development
  • A nonclinical (animal) juvenile toxicity study with a focus on renal development, bone development, and growth

Jardiance is a sodium glucose co-transporter-2 (SGLT2) inhibitor, and works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels. It is the third oral SGLT2 inhibitor to receive FDA approval, joining canagliflozin and dapagliflozin.

It is important to note that Jardiance is not indicated to treat type 1 diabetes or diabetic ketoacidosis.

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