FDA Accepts NDA for Triple Combination Tablet for Adults with Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company announced.

"Millions of adults with type 2 diabetes take multiple medicines to control their condition," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "If approved by the FDA, the combination tablet would be one of the first single-pill options with three complementary mechanisms of action to help manage blood glucose in adults with type 2 diabetes who could benefit from having empagliflozin and linagliptin as part of their treatment regimen, in addition to metformin."

Empagliflozin, marketed as Jardiance® in the U.S., is a sodium glucose co-transporter-2 (SGLT-2) inhibitor, which removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Linagliptin, marketed as Tradjenta® tablets in the U.S., is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which controls glucose by increasing hormones that stimulate the pancreas to secrete insulin and stimulate the liver to produce less glucose. Tradjenta is a once-daily, 5 mg tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The long-term cardiovascular safety profile of Tradjenta has been studied in two separate cardiovascular outcomes trials of adults with type 2 diabetes and increased cardiovascular risk. Tradjenta should not be used in people with type 1 diabetes or for the treatment of diabetic ketoacidosis. Tradjenta has not been studied in people with a history of pancreatitis.

Metformin, which decreases the production of glucose in the liver and its absorption in the intestine and improves the body's sensitivity to insulin and ability to utilize glucose, is the most commonly prescribed initial treatment for type 2 diabetes.

"Boehringer Ingelheim and Lilly continue to provide a range of treatment options to help improve overall care and outcomes for adults with type 2 diabetes," said Sherry Martin, M.D., vice president, Medical Affairs, Lilly. "We look forward to working with the FDA to make this combination tablet of empagliflozin, linagliptin and metformin XR available in hopes that it may help adults with type 2 diabetes better manage their condition with their healthcare providers."

The NDA is based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin XR investigational fixed-dose combination tablets and their individual components in healthy adults. Boehringer Ingelheim and Lilly plan to present results from the trials at a medical congress later this year.

Approximately 30 million Americans and an estimated 425 million people worldwide have diabetes, and nearly 24% of Americans with diabetes—or more than 7 million people—are undiagnosed. In the U.S., approximately 12% of those aged 18 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95% of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.

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