RIDGEFIELD, Conn., and INDIANAPOLIS — Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. have received approval from the Food and Drug Administration for Glyxambi (empagliflozin/linagliptin) tablets, a type 2 diabetes medication.

Boehringer Ingelheim and Lilly said Monday that Glyxambi is the first and only diabetes treatment in the United States to combine the dual mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet taken in the morning.

Glyxambi combines 10 mg or 25 mg of empagliflozin with 5 mg of linagliptin. SGLT2 inhibitors remove glucose through the urine by blocking blood glucose reabsorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

"Today’s medical community recognizes the need to treat type 2 diabetes from multiple fronts to help patients improve glycemic control," stated Paul Fonteyne, president and chief executive officer of Boehringer Ingelheim. "With Glyxambi, the dual inhibition of DPP-4 and SGLT2 — two proven targets in the treatment of type 2 diabetes — now provides U.S. physicians and patients with an option to simultaneously address multiple pathways to improve glycemic control. For patients uncontrolled on metformin, phase III trial results showed Glyxambi provided significantly greater reductions in blood glucose levels compared with either empagliflozin or linagliptin alone."

Glyxambi is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments.

"Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever," commented Mike Mason, vice president, U.S., Lilly Diabetes. "The approval of Glyxambi gives U.S. physicians and patients a first-in-class prescription medicine to help manage this condition. The approval is also a testament to our alliance’s commitment to adults living with type 2 diabetes."