The U.S. Food and Drug Administration has approved Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) tablets to improve glycemic control in adults with type 2 diabetes. Regulators in the European Union approved the drug in May.
Earlier this year, the FDA rejected the companies' first new drug application because of previously observed deficiencies at a Boehringer Ingelheim facility where Jardiance would be manufactured. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials, and the companies resubmitted the NDA in June. Eli Lilly said after the drug approval that the FDA's concerns have been resolved.
"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.”
Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. The drug’s safety and effectiveness were evaluated in seven clinical trials with 4,480 patients with type 2 diabetes receiving Jardiance. The pivotal trials showed the drug improved hemoglobin A1c levels compared to placebo.
Jardiance has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylureas, pioglitazone, and insulin. Jardiance should not be used to treat people with type 1 diabetes, in those who have increased ketones in their blood or urine, and in those with severe renal impairment, end stage renal disease, or in patients on dialysis.
The FDA is requiring four postmarketing studies for Jardiance:
- Completion of an ongoing cardiovascular outcomes trial.
- A pediatric pharmacokinetic/pharmacodynamic study.
- A pediatric safety and efficacy study. As part of the safety and efficacy study, the effect on bone health and development will be evaluated.
- A nonclinical (animal) juvenile toxicity study with a particular focus on renal development, bone development, and growth.
Boehringer developed the drug, and Lilly will help promote it in the United States.