FDA Approves Triple Combination Pill Trijardy for T2D
On January 27, 2020, the U.S. Food and Drug Administration (FDA) approved Trijardy XR, a triple combination drug of empagliflozin (Jardiance), linagliptin (Tradjenta), and metformin. The drug, manufactured by Eli Lilly and Company and Boehringer Ingelheim, combines the three drugs into a tablet to be taken once daily. Along with diet and exercise, the pill is designed to lower blood sugar. This is one of the first oral triple combination drugs approved by the FDA for people 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,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “We believe Trijardy XR has the potential to help adults with type 2 diabetes conveniently manage their treatment, especially those who are taking other medications and working on the necessary lifestyle changes.”
Trijardy was approved based on the strength of a pair of randomized, open-label trials that assessed each of the 3 combined therapy’s bioequivalence in healthy adults. The safety profile was proven to be consistent with that of each of its individual components.
Ralph DeFronzo, MD, professor and diabetes division chief at UT Health San Antonio, stated though adults with Type 2 diabetes are already on multi-medical treatments to reach their glycemic goals, new treatment options that lessen the number of medications one needs could improve health outcomes.
“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.”
Metformin is typically the first form of medication prescribed to people with Type 2 diabetes. Additional medications such as Jardiance and Tradjenta are used to help patients reach their glycemic goals.
Jardiance is a SGLT2 inhibitor, which blocks the reabsorption of glucose by the kidneys and increases glucose excretion in the urine. As a result, blood glucose is lowered. Jardiance has also been previously approved the reduced risk of cardiovascular death in adults with Type 2 diabetes and known cardiovascular disease.
Tradjenta is a DPP-4 inhibitor and increases insulin production and decreases glucose production.
Jeff Emmick, MD, PhD, vice president of Product Development at Lilly, said, “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.”
This drug is not intended for people with Type 1 diabetes or for the treatment of diabetic ketoacidosis.