Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes.
Empagliflozin, marketed as Jardiance in the US, is a sodium glucose co-transporter-2 (SGLT-2) inhibitor, which removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and 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).
Linagliptin, marketed as Tradjenta tablets in the US, is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which controls glucose by increasing hormones that stimulate the pancreas to secrete insulin and stimulate the liver to produce less glucose. Tradjenta is a once-daily, 5 mg tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The long-term cardiovascular safety profile of Tradjenta has been studied in two separate cardiovascular outcomes trials of adults with type 2 diabetes and increased cardiovascular risk. Tradjenta should not be used in people with type 1 diabetes or for the treatment of diabetic ketoacidosis. Tradjenta has not been studied in people with a history of pancreatitis.
Metformin, which decreases the production of glucose in the liver and its absorption in the intestine and improves the body’s sensitivity to insulin and ability to utilize glucose, is the most commonly prescribed initial treatment for type 2 diabetes.
The NDA is based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin XR investigational fixed-dose combination tablets and their individual components in healthy adults. Boehringer Ingelheim and Lilly plan to present results from the trials at a medical congress later this year.