NAPSR News: FDA Approves Jardiance® (empagliflozin) tablets for Type 2 Diabetes

WASHINGTON - Aug. 4, 2014 - PRLog -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company  received approval of Jardiance® (empagliflozin) tablets from the U.S. Food and Drug Administration (FDA). The drug is intended to improve glycemic control (blood sugar level) in adults with type 2 diabetes (T2D) only and should be used in correlation with proper diet and exercise.

The drug is administered in the form of 10mg or 25 mg tablets and is a sodium glucose co-transporter-2 (SGLT2) inhibitor. JARDIANCE's effectiveness stems from its ability to block the reabsorption of glucose in the kidney thus increasing glucose excretion and lowering the blood glucose level in Type 2 patients. "Many adults with type 2 diabetes still have difficulty controlling their blood sugar levels even with treatment. There is a critical need for new treatment options to help these patients," said Christophe Arbet-Engels, M.D., Ph.D., vice president, metabolic-clinical development and medical affairs, BIPI. "JARDIANCE is a new option that has been shown in clinical trials to reduce blood sugar levels. Although not approved for weight loss, modest weight loss was also observed in these clinical trials."

The clinical trial was conducted involving 13,000 adults with Type 2 diabetes and FDA approval was based on Phase III studies which indicated reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months)."Today's FDA approval of JARDIANCE provides an exciting new option in the treatment of adults with type 2 diabetes and demonstrates our commitment to these patients, as it marks the third diabetes medicine to emerge from our alliance pipeline," said Enrique Conterno, president, Lilly Diabetes.

Approximately 29.1 million individuals currently suffer from diabetes mellitus in the United States, according to the Centers for Disease Control and Preventions. Type 2 diabetes is the most common of all diabetes cases affecting an estimated 85 to 95 percent. Diabetes is a condition that results from the body’s inability to properly regulate the blood glucose level, which is mainly characterized by glycosuria.  In type 2 diabetes the body does not respond effectively to the insulin it produces.

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