Boehringer Ingelheim, Lilly get FDA green light for Trijardy

Adult patients with Type 2 diabetes now have a triple-combination tablet treatment option. The Food and Drug Administration has approved Boehringer Ingelheim and Eli Lilly’s Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended-release tablets).

The drug is indicated to lower blood sugar in adults with type 2 diabetes, along with diet and exercise.

Trijardy XR provides three type 2 diabetes medicines in one pill, including Jardiance (empagliflozin), Tradjenta (linagliptin) and metformin hydrochloride extended release.

“Many adults living with Type 2 diabetes 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, professor and diabetes division chief of UT Health San Antonio. “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. In addition, Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment.”

Jardiance and Tradjenta are once-daily tablets used along with diet and exercise to lower blood sugar in adults with Type 2 diabetes. Jardiance also is approved to reduce the risk of cardiovascular death in adults with Type 2 diabetes who have known cardiovascular disease.

“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, Boehringer Ingelheim's vice president, clinical development & medical affairs, cardio-metabolism & respiratory medicine. “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.”

“The approval of Trijardy XR reflects our commitment to the diabetes community and to innovation that addresses evolving needs,” said Jeff Emmick, Lilly vice president, product development. “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. We look forward to making this new option available soon.”

Trijardy XR will be available in four different dosages, including: 5 mg empagliflozin/2.5 mg linagliptin/1000 mg metformin HCl ER; 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin HCl ER; 12.5 mg empagliflozin/2.5 mg linagliptin/1000 mg metformin HCl ER; and 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin HCl ER.