Diabetes Drug Empagliflozin (Jardiance) Wins FDA OK on Second Try


August 01, 2014

The glucose-reducing drug empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals) won approval today from the US Food and Drug Administration (FDA) after the drug maker corrected manufacturing problems that caused the agency to say no in March.

The sodium glucose cotransporter 2 (SGLT2) is indicated for improving glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. Clinicians can prescribe empagliflozin by itself or as an adjunct to other drugs for type 2 diabetes. It is not indicated for patients with type 1 diabetes, diabetic ketoacidosis, severe renal impairment, or end-stage renal disease or for patients receiving dialysis.

Empagliflozin lowers plasma glucose levels by increasing the amount of glucose excreted in urine. It is the third oral SGLT2 inhibitor to receive FDA approval, joining canagliflozin (Invokana, Janssen Pharmaceuticals) and dapagliflozin (Farxiga, AstraZeneca/BMS). The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for empagliflozin in March.

The FDA stated in a news release today that it determined empagliflozin to be effective and safe on the basis of 7 clinical trials involving nearly 4500 patients with type 2 diabetes. Those receiving the drug had lower hemoglobin A1c levels compared with other patients who received a placebo.

Urinary tract infections and female genital infections were the most common adverse effects observed in the clinical trials.

The FDA told Medscape Medical News that Boehringer Ingelheim corrected the manufacturing problems that held up approval of empagliflozin in March.

Today's decision, however, comes with strings attached. The manufacturer must conduct 4 postmarketing studies, including the completion of a cardiovascular outcomes study now underway, and 3 others delving into pediatric issues.

More information on today's announcement is available on the FDA Web site.


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