Boehringer, Lilly Say FDA OKs Jardiance Tablets For Adults With Type 2 Diabetes

(RTTNews) - Boehringer Ingelheim Pharmaceuticals, Inc. or BIPI and Eli Lilly and Co. (LLY) announced the U.S. Food and Drug Administration or FDA approved Jardiance tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes or T2D. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis.

JARDIANCE, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 or SGLT2 inhibitor. JARDIANCE works by blocking the reabsorption of glucose in the kidney, enhancing glucose excretion and lowering blood glucose levels in adults with T2D who have elevated blood glucose levels.

The FDA approval is based on results from a large program comprising over 10 multinational trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE significantly reduced hemoglobin A1C and fasting blood sugar after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Though JARDIANCE is not approved for reducing weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.

The most common adverse reactions associated with JARDIANCE were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of JARDIANCE and sulfonylurea or insulin.

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.