FDA approves diabetes combo drug Trijardy XR

January 28, 2020

The triple-combination tablet is taken once daily to lower blood sugar in adults.

The FDA approved Trijardy XR (triple-combination empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to treat type 2 diabetes in adults, according to a news release.

Trijardy XR combines Jardiance, Tradjenta, and metformin hydrochloride extended release into one pill, which, when taken along with diet and exercise, can lower blood sugar in adults, according to the release.

"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, MD, vice president Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc., in the news release. "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 new pill is not recommended for patients with type 1 diabetes or diabetic ketoacidosis and has not been studied in people with a history of pancreatitis. It is unknown if those with a history of pancreatitis will be at an increased risk for the development of pancreatitis while using Trijardy XR. The pills labeling includes a warning for lactic acidosis a rare but serious complication that can occur due to metformin accumulation, and is common to all products containing metformin, the release says.

"The approval of Trijardy XR reflects our commitment to the diabetes community and to innovation that addresses evolving needs," Jeff Emmick, MD, vice president, Product Development, Lilly, says in the release. "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."

According to the release, the pill will be available in four different dosages including:

·      5 mg empagliflozin/2.5 mg linagliptin/1000 mg metformin 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.