FDA approves combined drug to improve glycemic control in diabetes patients

February 2, 2015

The first-in-class combined medication for improving glycemic control in adults with type 2 diabetes has been approved by FDA.

The first-in-class combined medication for improving glycemic control in adults with type 2 diabetes has been approved by FDA.

Glyxambi (empagliflozin/linagliptin, Boehringer Ingelheim/Eli Lilly) tablets are to be used as an adjunct to diet and exercise for the improvement of glycemic control when both empagliflozin and linagliptin are considered appropriate treatments.

The new agent is the first treatment for diabetes to combine 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. As an SGLT2 inhibitor, empagliflozin works by blocking blood glucose reabsorption in the kidney, thereby removing glucose through the urine. As a DPP-4 inhibitor, linagliptin works by increasing hormones that stimulate the liver to produce lower glucose levels and increasing hormones that aid the pancreas with insulin production.

The tablet, which is to be taken in the morning, includes empagliflozin 10 or 25 mg and linagliptin 5 mg. When compared with either empagliflozin or linagliptin alone as an add-on to metformin, use of the combined drug has been found to result in significantly greater reductions in hemoglobin A1c levels.

In a phase 3 clinical trial, which served as the basis for FDA approval, the change from baseline in A1c at 24 weeks was evaluated in 686 adults with type 2 diabetes and A1c between 7.0% and 10.5%. In those randomly assigned to receive empagliflozin/linagliptin 10 mg/5 mg or 25 mg/5 mg, the percentage achieving an A1c <7% was 58% and 62%, respectively. In comparison, in those randomized to receive either empagliflozin 10 mg, empagliflozin 25 mg, or linagliptin 5 mg, the percentage achieving Alc <7% was 28%, 33%, and 36%, respectively.

Empagliflozin/linagliptin is not to be used in treating patients with type 1 diabetes or those with diabetic ketoacidosis. The new combined drug is not recommended for patients who are allergic to either empagliflozin or linagliptin, have severe renal impairment, or for patients who have end-stage renal disease or are on dialysis.