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Jardiance Receives FDA Approval for Type 2 Diabetes Mellitus
- Updated: August 20, 2014
Type 2 diabetes mellitus, also referred to as adult onset diabetes, is characterized as an assortment of dysfunctions by hyperglycemia, resulting from a combination of insulin action resistance, insulin secretion inadequacy, and glucagon secretion excess or inappropriateness. In simple terms, this group of metabolic diseases involves high levels of blood sugar that occur over a long period of time.
Currently, there are millions of people in the United States alone who live with type 2 diabetes mellitus and although new medications and treatments have been developed over the years, researchers push on to find even more effective solutions. Earlier this month, the United States Food and Drug Administration (FDA) approved a new drug called Jardiance (Empagliflozin) to treat this particular form of diabetes.
Available in tablet form and distributed by Bochringer Ingellheim Pharmaceuticals, Inc., Jardiance, coupled with regular exercise and proper diet, is shown to improve glycemic control in adults living with type 2 diabetes mellitus. Officially known as a “sodium glucose co-transporter 2 inhibitor”, this new drug helps by blocking the reabsorption of glucose by the kidneys. However, Jardiance is also capable of lowering elevated levels of blood glucose.
According to the Office of Drug Evaluation II in the FDAs Center for Drug Evaluation and Research’s director, Dr. Curtis J. Rosebraugh, in an effort to control blood sugar levels more efficiently, Jardiance can be used as a standalone drug or in conjunction with existing treatments to include but not limited to insulin, metformin, sulfonylureas, and pioglitazone.
To validate both effectiveness and safety, 4,480 patients participated in clinical trials. For patients given Jardiance opposed to placebo, there was a marked improvement in glycated hemoglobin levels. While Jardiance is an excellent treatment for type 2 diabetes mellitus, it is not intended for people with type 1 diabetes mellitus, severe renal impairment, end-stage renal disease, and diabetes ketoacidosis, as well as patients receiving kidney dialysis.
Even with the FDA’s recent approval of Jardiance, four post-marketing studies are being required to include an ongoing cardiovascular outcome trial, pediatric safety and efficacy study specific to development and bone health, pediatric pharmacokinetic / pharmacodynamics study, and non-clinical juvenile toxicity study that focuses on growth, along with bone and renal development.