The glucose-reducing drug empagliflozin (Jardiance) won approval today from the US Food and Drug Administration (FDA) after Boehringer Ingelheim corrected manufacturing problems that caused the agency to say "no" in March….
The sodium glucose cotransporter 2 (SGLT2) inhibitor 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) and dapagliflozin (Farxiga). 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 that it determined empagliflozin to be effective and safe on the basis of 7 clinical trials involving nearly 4,500 patients with type 2 diabetes. Those receiving the drug had lower HbA1c 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 added that Boehringer Ingelheim corrected the manufacturing problems that held up approval of empagliflozin in March. However the decision comes with a few 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.
- Empagliflozin, an SGLT2 inhibitor, lowers plasma glucose levels by increasing the amount of glucose excreted in urine.
- Urinary tract infections and female genital infections were the most common adverse effects
- It is the third oral SGLT2 inhibitor to receive FDA approval, joining canagliflozin and dapagliflozin.