Boehringer Ingelheim, Eli Lilly File NDA for Diabetes Combination Product

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company report that FDA has accepted the filling of a new drug application for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with Type 2 diabetes.

If granted approval by the FDA, this combination brings together in one tablet the mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor (empagliflozin)  and a dipeptidyl peptidase-4 (DPP-4) inhibitor (linagliptin). SGLT2 inhibitors remove excess glucose through the urine by blocking glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

Boehringer Ingelheim’s linagliptin, marketed as Tradjenta®, was approved by FDA in 2011, and is a  once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with Type II diabetes. Empagliflozin is in Phase III development for treatment of Type II diabetes. .

In January 2011, Boehringer Ingelheim and Eli Lilly and Company formed an alliance in diabetes.

Source: Eli Lilly


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