Boehringer and Lilly Announce sNDA Approval for Tradjenta

TRADJENTA (linagliptin) 5mg tablets by Boehringer Ingelheim and Eli Lilly
TRADJENTA (linagliptin) 5mg tablets by Boehringer Ingelheim and Eli Lilly
Boehringer Ingelheim and Lilly announced the FDA approval of their supplemental new drug application (sNDA) for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin.

The FDA's approval 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). At 24 weeks, Tradjenta plus basal insulin demonstrated a placebo-adjusted reduction in hemoglobin A1C of 0.65% from a baseline A1C of 8.3%. The rate of hypoglycemia also was similar in both groups (21.4% in Tradjenta vs. 22.9% in placebo).

Tradjenta was also studied in people with severe chronic renal impairment. Data from a 52-week, double-blind, randomized, placebo-controlled trial showed that use of Tradjenta 5mg plus other glucose-lowering therapies in this patient population after 12 weeks of treatment showed statistically significant improvements in A1C with an adjusted mean change of -0.6%, compared to placebo. Efficacy was
maintained for 52 weeks with an adjusted mean change from baseline in A1C of -0.7%, compared to placebo.

Tradjenta, a dipeptidyl peptidase-4 inhibitor, is already indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus as monotherapy or combination with
metformin, sulfonylurea, or pioglitazone. Tradjenta acts by increasing incretin levels, stimulating the release of insulin in a glucose-dependent manner.

For more information call (800) 542-6257 or visit www.tradjenta.com.