This article is more than 5 years old. Information may no longer be current.
FDA approves Glyxambi tablets for adults with type 2 diabetes
Click Here to Manage Email Alerts
The U.S. Food and Drug Administration has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, for adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments.
The drug combines the active ingredients of the Lilly-Boehringer products Jardiance (empagliflozin)and Tradjenta (linagliptin). Glyxambi combines 10 mg or 25 mg of empagliflozin with 5 mg of linagliptin.
Glyxambi is the first diabetes treatment in the U.S. to combine a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet. SGLT2 inhibitors remove glucose through the urine by blocking blood glucose re-absorption 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," said Paul Fonteyne, president and CEO 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."
Patients with ESRD should not take the drug.