FDA Approves Triple-Combination Drug for Diabetes Glycemic Control

The US Food and Drug Administration (FDA) has approved triple-combination empagliflozin/linagliptin/metformin hydrochloride extended release tablets (Trijardy XR) for the reduction of blood sugar in adults with type 2 diabetes, along with diet and exercise.

The approval of the joint Eli Lilly and Company and Boehringer Ingelheim drug combines 3 currently marketed type 2 diabetes therapies to provide simplistic treatment for glycemic control. Empagliflozin (Jardiance) and linagliptin (Tradjenta) are both currently approved as once-daily oral tablets for the reduction of blood sugar, along with diet and exercise.

Empagliflozin has also been previously approved the reduced risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.

Trijardy XR was approved based on the strength of a pair of randomized, open-label trials which assessed each of the 3 combined therapy’s bioequivalence in healthy adults. Its safety profile was proven to be consistent with that of each of its individual components.

That said, the therapy is not intended for patients with type 1 diabetes, or for the treatment of diabetic ketoacidosis. It has not yet been studied in patients with a history of pancreatitis, and investigators are uncertain whether it harbors risk for pancreatitis development.

Mohamed Eid, MD, MPH, MHA, vice president of Clinical Development & Medical Affairs of Boehringer’s Cardio-Metabolism & Respiratory Medicine, emphasized the significance of each individual drug, and their potential as a combined treatment, in patients with type 2 diabetes.

"We are proud to offer Trijardy XR as a new once-daily option combining three well-established medicines, including an extended-release version of metformin, the most commonly prescribed initial treatment for type 2 diabetes, Jardiance, the most prescribed SGLT2 inhibitor, and Tradjenta, the only single-dose DPP-4 inhibitor," Eid said in a statement.

Ralph DeFronzo, MD, professor and diabetes division chief at UT Health San Antonio, said many adults with type 2 diabetes are already on a multiple-therapy treatment regimen solely for glycemic control. These patients also need additional agents to reach A1C target levels.

“Adding new medicines to an individual's plan can be challenging for some, which is why new treatment options that can help improve blood sugar without the burden of an increased pill count are important,” DeFronzo said. “Having three different diabetes medications in a single tablet is an important advance in diabetes treatment."

Jeff Emmick, MD, PhD, vice president of Product Development at Lilly, called the Trijardy XR approval a reflection of the company’s commitment to diabetes patient care and innovation.

“We developed Trijardy XR because many people with type 2 diabetes need help managing this complex condition without adding more pills to their treatment plan,” Emmick said. “We look forward to making this new option available soon."