Linagliptin Receives Approval in Europe for the Treatment of Type ... ( RIDGEFIELD Conn. and INDIANAPOLIS Aug...)

Linagliptin Receives Approval in Europe for the Treatment of Type 2 Diabetes

Date:8/25/2011

RIDGEFIELD, Conn., and INDIANAPOLIS, Aug. 25, 2011 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today received Marketing Authorization from the European Commission for linagliptin 5 mg film-coated tablets (to be marketed under the trade name Trajenta® in Europe) for the treatment of adults with type 2 diabetes. The European Commission has approved linagliptin in combination with metformin and metformin plus sulfonylurea.(1) Linagliptin is also approved for use as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.(1)

In the U.S., linagliptin 5 mg is marketed under the trade name Tradjenta™ (linagliptin) tablets and was approved by the U.S. Food and Drug Administration (FDA) in May 2011 to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin. Linagliptin is also approved for use in other countries, including Japan (trade name Trazenta).

"The Phase III clinical trial program has demonstrated efficacy with linagliptin in the treatment of adults with type 2 diabetes," said Prof. Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim. "We are delighted that linagliptin will soon be available to patients across Europe."

Studies show linagliptin has a demonstrated efficacy and safety profile, reducing hemoglobin A1C (HbA1C or A1C) levels by a mean of -0.6 to -0.7 percent(2,3) (compared to placebo). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three mo
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