The approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults.
The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company’s Trijardy XR for lowering blood sugar in adults with type 2 diabetes.
Trijardy XR is a triple-combination pill that includes Jardiance (empagliflozin), Tradjenta (linagliptin) and metformin hydrochloride extended release. It is prescribed along with diet and exercise for decreasing blood glucose levels in type 2 diabetes.
In the U.S., Jardiance and Radjenta are once-daily tablet used to treat adults with type 2 diabetes. Jardiance has also been approved to decrease the risk of cardiovascular death in adults with type 2 diabetes with known cardiovascular disease. It is not approved for type 1 diabetes or for individuals with diabetic ketoacidosis. Tradjenta is also not prescribed for type 1 diabetic patients or for diabetic ketoacidosis.
“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, 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.”
DeFronzo added, “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 approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults. The safety profile of Trijardy XR was consistent with the individual components. The drug combination will be available in four different dosages of the three different drugs, empaglifozin/linagliptin/metformin: 5mg/2.5mg/1000mg; 10mg/5mg/1000mg; 12.5mg/2.5mg/1000mg; and 25mg/5mg/1000mg.
Jardiance is also in two other two-drug combinations, Glyxambi/Jentuadueto (empagliflozin/linagliptin) and Synjardy (empagliflozin/metformin).
Boehringer is expected to report more than $2 billion in Jardiance-related product sales for 2019, while Lilly indicated it brought in about $677 million from the franchise in the first three quarters of 2019. Jardiance was initially launched in 2014 and is the top-selling SGLT2 inhibitor in the U.S., commanding about a 50% market share in the U.S. and a 41% market share worldwide. Its closest competitor is AstraZeneca’s Farxiga (dapagliflozin).
AstraZeneca reported $1.1 billion Farxiga sales in the first quarter of 2019 alone.
On January 17, Alembic Pharmaceuticals received tentative approval from the FDA for its generic of Jardiance.
Mohamed Eid, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine for Boehringer, said, “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. 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.”
