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Eli Lilly, Boehringer Say FDA Okays Tradjenta As Add-On Therapy To Insulin

Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. (LLY) said Friday that the U.S. Food and Drug Administration has approved a supplemental new drug application, or sNDA, for Tradjenta tablets for use as add-on therapy to insulin.

Tradjenta (linagliptin) is a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The drug can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes, such as metformin, sulfonylurea, pioglitazone or insulin. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).

The FDA's decision is based on data from a 52-week, phase 3 trial demonstrating the efficacy of Tradjenta in combination with insulin (with or without metformin and/or pioglitazone).

Results from the trial showed that adding Tradjenta to insulin produced better glucose control than insulin alone, with similar incidence of hypoglycemia (low blood sugar) in both treatment groups. Tradjenta belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once-daily).

Additionally, the FDA-approved label includes a clinical study in people with severe chronic renal impairment. Data from a 52-week, double-blind, randomized, placebo-controlled trial showed that use of Tradjenta 5 mg plus other glucose-lowering therapies in this patient population provided a statistically significant improvement in glycated hemoglobin, compared to placebo.

"Many people with type 2 diabetes taking insulin also require additional medication. With today's FDA decision, Tradjenta can be an effective add-on therapy with a demonstrated safety profile to help adult patients on insulin to improve their blood sugar control," said John Smith, senior vice president for clinical development and medical affairs, Boehringer Ingelheim.

Smith further said, "Tradjenta is the only once-daily, one-dose drug in its class without the need for dose adjustment regardless of declining renal function or hepatic impairment."

Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day. Among many considerations when treating patients with type 2 diabetes, about 40 percent of individuals have some degree of renal impairment.

Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin. About 25.8 million Americans and an estimated 366 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.

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