FDA Approves New Drug for Type 2 Diabetes: Jardiance®
The U.S. Food and Drug Administration (FDA) has approved the diabetes drug Jardiance® (empagliflozin) to improve glycemic control in adults with type 2 diabetes.
The FDA states that the Jardiance® tablets should be used in addition to diet and exercise to control type 2 diabetes. Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, says that “[Jardiance®] can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
The drug’s safety and effectiveness were evaluated in 7 clinical trials involving 4,480 patients with type 2 diabetes who were using Jardiance®. The studies showed that Jardiance® improved blood sugar control as demonstrated by improved hemoglobin A1c (a measure of blood sugar control) compared to the placebo. The FDA will require the manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc., to complete 4 post-marketing studies for this new diabetes drug.
The FDA notes that type 2 diabetes affects approximately 26 million people and makes up over 90% of the diabetes cases in the United States. High blood sugar levels can increase the risk for serious complications, such as heart disease, blindness, and nerve and kidney damage.”
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