Lilly Diabetes Drug Secures FDA Approval

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The U.S. Food and Drug Administration has approved a type 2 diabetes treatment that is co-developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Boehringer Ingelheim Pharmaceuticals Inc. in Connecticut. The approval of Jardiance comes after months of clinical trials that involved more than 13,000 adults. Aug. 1, 2014

News Release

RIDGEFIELD, Conn., and INDIANAPOLIS, Ind. - Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Jardiance (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

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

Patients should not take JARDIANCE if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in JARDIANCE. JARDIANCE can cause some people to have dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause patients to feel dizzy or faint.

"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 FDA approval is based on results from a large clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE significantly reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) 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. Although JARDIANCE is not approved for lowering 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.

"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.

About Diabetes

Approximately 29 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

Source: Eli Lilly and Co. and Boehringer Ingelheim Pharmaceuticals Inc.