FDA approves Jardiance tablets for adults with type 2 diabetes

RIDGEFIELD, Conn., and INDIANAPOLIS—Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company have announced that 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 people with diabetic ketoacidosis (increased ketones in the blood or urine).

In January 2011, Boehringer Ingelheim and Lilly announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance was created to leverage the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Jardiance is the third product from the alliance to be approved by FDA

Jardiance, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor that 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.

"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. "]ardiance 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 3 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.

"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.

In separate action ealier this month, the U.S. prescribing information for Jentadueto® (linagliptin and metformin hydrochloride) tablets was broadened to include clinical trial data that showed linagliptin co-administered with metformin provided statistically significant decreases in blood glucose compared with linagliptin alone in treatment-naive adults with type 2 diabetes and high baseline average plasma glucose concentrations (A1C of ≥8.5 to ≤12.0 percent). The data, based on results from a prospective 24-week Phase 4 clinical trial, have been added to the "Clinical Studies" section of the Jentadueto U.S. prescribing information.

"We are extremely pleased with the addition to the Jentadueto label. These data support the use of Jemtadueto as an initial type 2 diabetes treatment option in an important patient population—treatment-naive adults who have high baseline A1C levels," said Arbet-Engels. "In addition, these data reinforce the use of Jentadueto, as an adjunct to diet and exercise, in helping adults with type 2 diabetes improve glycemic control."

The 24-week, randomized, double-blind study assessed the efficacy and safety of linagliptin (5 mg per day) in combination with metformin (1500 to 2000 mg per day; n=159) vs. linagliptin (5 mg per day; n=157) alone in treatment-naive adults with type 2 diabetes and high baseline A1C. The primary endpoint of the trial—change from baseline in A1C after 24 weeks—demonstrated that initial therapy with the combination of linagliptin and metformin reduced A1C levels from baseline by 2.9 percent compared with 2.0 percent for linagliptin alone. There was a statistically significant mean difference in A1C between the combination and linagliptin alone of -0.84 percent. Key secondary findings showed fasting plasma glucose levels were significantly decreased with the combination treatment compared with linagliptin alone

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.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation. The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine. In 2013, Boehringer Ingelheim’s net sales were about $18.7 billion (14.1 billion euro). R&D expenditure in the prescription medicines business corresponds to 19.5 percent of its net sales.

Lilly has been a global leader in diabetes care since 1923, when the company introduced the world's first commercial insulin. Today Lilly is building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—the company strives to make life better for all those affected by diabetes around the world.