Lilly, Boehringer Ingelheim receive FDA approval for Tradjenta sNDA to treat type 2 diabetes

Published on August 18, 2012 at 12:35 AM · No Comments
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Tradjenta® (linagliptin) tablets for use as add-on therapy to insulin. TRADJENTA is a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and 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). The trial results showed 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 (HbA1c or A1C) compared to placebo (placebo-adjusted reduction of 0.7 percent).

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