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Empagliflozin/Linagliptin Tablet Submitted for FDA Review for Treatment of Type-2 Diabetes in Adults

Filing follows completion of phase III trial

The FDA has accepted the filing of a new drug application (NDA) for an investigational combination tablet consisting of empagliflozin and linagliptin (Boehringer Ingelheim/Eli Lilly) for the treatment of adults with type-2 diabetes.

If approved by the FDA, the medication will combine, for the first time in one tablet, the mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor. SGLT2 inhibitors remove excess glucose through the urine by blocking glucose reabsorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and that stimulate the liver to produce less glucose.

The filing follows the completion of a phase III clinical registration trial designed to evaluate the efficacy and safety of the empagliflozin/linagliptin combo compared with the individual components in adults with type-2 diabetes. Findings from this study are expected to be announced later this year.

Linagliptin, which is marketed as Tradjenta tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with type-2 diabetes. Tradjenta should not be used in patients with type-1 diabetes or for the treatment of diabetic ketoacidosis. The drug has not been studied in patients with a history of pancreatitis.

Source: Eli Lilly; April 14, 2014.

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