FDA Approves Triple-Combination Tablet for Adults with Type 2 Diabetes

The FDA has approved triple-combination extended release tablets to lower blood sugar in adults with type 2 diabetes (T2D), when combined with diet and exercise. The pill, marketed as Trijardy XR, combines 3 frequently used medications for T2D: empagliflozin (Jardiance), linagliptin (Tradjenta), and metformin hydrochloride extended release.

Empagliflozin and linagliptin are once-daily tablets used along with diet and exercise to lower blood sugar. Empagliflozin is also approved to reduce the risk of cardiovascular death in adults with T2D who have known cardiovascular disease.

“Many adults living with [T2D] who are already on a treatment plan including multiple medications still struggle to keep their blood sugar under control, and may require additional agents to reach their A1C targets,” said Ralph DeFronzo, MD, diabetes division chief of UT Health San Antonio, in a press release.

The pill will be available in 4 different dosages: 5 mg empagliflozin/2.5 mg linagliptin/1000 mg metformin hydrochloride (HCL) extended-release; 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin HCL extended-release; 12.5 mg empagliflozin/2.5 mg linagliptin/1000 mg metformin HCL extended-release; and 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin HCL extended-release.

The FDA approval is based on 2 randomized open-label trials that assessed the bioequivalence of the 3 drugs and their individual components in healthy adults. The safety profile of the triple combination tablet was found to be consistent with its individual components.

Trijardy XR is not intended for patients with severe kidney problems, end stage renal disease, are on dialysis, have metabolic acidosis, or have diabetic ketoacidosis. The labeling includes a warning for lactic acidosis.

The triple-combination therapy is marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.

REFERENCE

US FDA approves only triple-combination tablet with Jardiance for adults with type 2 diabetes [news release]. Ridgefield, Conn; Jan 27, 2020. Eli Lilly and Co. investor.lilly.com/news-releases/news-release-details/us-fda-approves-only-triple-combination-tablet-jardiancer-adults. Accessed Jan 29, 2020.