FDA Approves Jardiance for Type 2 Diabetes
A new SGLT2 inhibitor, Jardiance (empagliflozin), has been approved by the FDA for the treatment of people with type 2 diabetes.
In announcing the approval, FDA's Curtis J. Rosebraugh, MD, said that "Jardiance provides an additional treatment option for the care of patients with type 2 diabetes. It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
Jardiance, a sodium glucose co-transporter 2 (SGLT2) inhibitor, works by blocking the reabsorption of glucose (blood sugar) 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, noted the agency. "The pivotal trials showed that Jardiance improved hemoglobin A1c levels (a measure of blood sugar control) compared to placebo."
Jardiance, which is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., 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 (diabetic ketoacidosis); and in those with severe renal impairment, end stage renal disease, or in patients on dialysis.
According to a press release, 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.
The FDA also cautions that Jardiance can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk.
The most common side effects of Jardiance are urinary tract infections and female genital infections.
Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.