The US Food and Drug Administration announced the approval of Jardiance (empagliflozin) to treat adults with type 2 diabetes.
The US Food and Drug Administration (FDA) announced the approval of Jardiance (empagliflozin) tablets to treat adults with type 2 diabetes.
There are estimated to be around 26 million people in the country with type 2 diabetes and this new drug is meant to be part of the treatment for those people that also includes diet and exercise, according to a statement from the FDA.
Curtis Rosebraugh, MD, MPH, the director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said the new drug is thought to be an effective addition to the treatment of diabetes.
“It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes,” he noted.
The FDA said Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor and it works by blocking the kidney from reabsorbing glucose, increasing the excretion of glucose, and lowering blood glucose levels in patients who have elevated numbers.
Studies for the drug involved 4,480 patients with type 2 diabetes. Results from those studies showed improved hemoglobin A1c levels over patients being treated with a placebo.
Jardiance is not approved for patients with type 1 diabetes, those who have increased ketones in their blood or urine, or for those with severe renal impairment, end stage renal disease or those on dialysis. The FDA statement noted that Jardiance still is required to go through more studies including some involving pediatric patients and an ongoing cardiovascular outcome trial.
The drug has been shown to cause dehydration, which can cause hypotension resulting in dizziness and/or fainting and a reduction in renal function. The risk is higher for elderly patients as well as those with impaired renal function or those on diuretics to treat other conditions, according to the FDA. Other possible side effects include urinary tract infections and female genital infections.
Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc. of Ridgefield, CT. Eli Lilly and Co. will co-promote the drug.