FDA approves Synjardy XR tablets for adults with type 2 diabetes

New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise.

Synjardy XR is a combination of empagliflozin and metformin — two medicines with complementary mechanisms of action — to help improve blood glucose in adults with type 2 diabetes. Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Synjardy XR is the fourth FDA-approved treatment that contains empagliflozin. Metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.

"Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage their condition," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "With Synjardy XR, the eighth FDA-approved treatment to emerge from our partnership with Lilly, adults with type 2 diabetes now have another convenient daily option to help them reach their glycemic goals, whether they are already being treated or are just at the beginning of their treatment."

The FDA approval of Synjardy XR is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes. Synjardy XR is not for the treatment of type 1 diabetes or diabetic ketoacidosis.