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).

"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, M.D., Ph.D., senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "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, approximately 40 percent of individuals have some degree of renal impairment. With TRADJENTA, no dose adjustment is required regardless of declining renal function or hepatic impairment.

Source:

Boehringer Ingelheim Pharmaceuticals, Inc.

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