FDA Approves New Drug Jardiance to Treat Type-2 Diabetics

The FDA panel has voted for a new drug Jardiance to treat adults with type-2 diabetes.

In a latest announcement, the U.S. Food and Drug Administration gave a nod to Jardiance (empagliflozin) that is meant to be taken in addition with diet and physical activity so as to boost the glycemic control in adults with type-2 diabetes, the most common form of diabetes affecting 26 million Americans.

Type-2 diabetes, also known as non-insulin-dependent diabetes, is a chronic condition that affects the way body metabolized sugar. This type of diabetes - which accounts for over 90 percent of the diabetes cases diagnosed in the U.S. - occurs when the body fails to produce insulin. High blood sugar levels increase the risk of serious complications that include heart diseases, blindness, and nerve and kidney damage.

"Jardiance provides an additional treatment option for the care of patients with type 2 diabetes," said Curtis J. Rosebraugh, M.D., M.P.H., 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 marketed by Boehringer Ingelheim Pharmaceuticals, is basically a glucose co-transporter 2 (SGLT2) inhibitor that function by blocking the reabsorption of glucose by the kidney, elevating glucose excretion and reducing the levels of blood glucose in diabetics who have high levels of blood glucose.

In order to verify the safety and effectiveness of the drug, researchers conducted seven clinical trials that included 4,480 patients with type-2 diabetes. These patients were given Jardiance. The pivotal trials revealed that Jardiance was more effective in enhancing hemoglobin A1c levels as compared to placebo.

The newly approved drug was evaluated as a stand-alone therapy and also in combination with other type-2 diabetes therapies that include metformin, sulfonylureas, pioglitazone and insulin. However, Jardiance should not be used to treat those with type-1 diabetes or those who have high levels of ketones in their blood or urine. The drug is not approved for those with severe renal impairment, end stage renal disease or those kept on dialysis.

The FDA panel demanded four post-marketing studies for Jardiance. The side effects noticed among patients included dehydration, causing drop in blood pressure due to which they experienced dizziness or fainting and those on diuretics to treat other conditions that were more susceptible to risk.

One of the most common side effects was urinary tract infection and female genital infections.