US FDA Approves Only Triple-Combo Tablet with Jardiance® for Adults with T2D

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By : dLife Editors

The U.S. Food and Drug Administration has approved Trijardy™ XR 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.

Trijardy XR is marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.

“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 Dr. Ralph DeFronzo, 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,” he added.

In addition, DeFronzo said Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control, and having three different diabetes medications in a single tablet is an important advance in diabetes treatment.

In the U.S., both Jardiance and Tradjenta are once-daily tablets used along with diet and exercise to lower blood sugar in adults with Type 2 diabetes.

Jardiance is also approved to reduce the risk of cardiovascular death in adults with Type 2 diabetes who have known cardiovascular disease.

Jardiance is not for people with Type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). Tradjenta is not for people with Type 1 diabetes or for the treatment of diabetic ketoacidosis. Tradjenta has not been studied in people with a history of pancreatitis and it is unknown if using Tradjenta increases the risk of developing pancreatitis in these people.

The FDA approval of Trijardy XR is based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and metformin hydrochloride extended-release fixed-dose combination tablets and their individual components in healthy adults. The safety profile of Trijardy XR was found to be consistent with its individual components.

Trijardy XR 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.

For more information, you can access the complete press release below.

Eli Lilly and Company.

Source:

  1. Eli Lilly and Company. (2020, Jan. 27). US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes. PR Newswire. Retrieved Jan. 28, 2020 from https://prnmedia.prnewswire.com/news-releases/us-fda-approves-only-triple-combination-tablet-with-jardiance-for-adults-with-type-2-diabetes-300993928.html

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