FDA Green Lights Lilly Three-in-One Diabetes Pill

INDIANAPOLIS (Inside INdiana Business) – The U.S. Food and Drug Administration has approved a triple-combination tablet from Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The medication offers three Type 2 diabetes medicines in one pill, including Jardiance, Tradjenta and metformin hydrochloride extended release.

The FDA approval of Trijardy XR was based on two randomized trials that tested the pill’s effectiveness in healthy adults. Trijardy XR’s safety profile was found to be consistent with each individual tablet on its own.

“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, M.D., professor and diabetes division chief, 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.”

The pill is intended to lower blood sugar in individuals with type 2 diabetes when paired with diet and exercise and make it easier to manage dosages. Rather than taking three once-daily pills, a patient can now take a three-in-one pill to address their complex needs.

“The approval of Trijardy XR reflects our commitment to the diabetes community and to innovation that addresses evolving needs,” said Jeff Emmick, M.D. Ph.D., vice president, Product Development, Lilly. “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.”

Lilly says the Trijardy XR pill will soon be available in four different dosages.