INDIANAPOLIS (dpa-AFX) - Boehringer Ingelheim and Eli Lilly and Co. (LLY) received Marketing Authorization from the European Commission for linagliptin 5 mg film-coated tablets for the treatment of adults with type 2 diabetes. The linagliptin 5 mg film-coated tablets is to be marketed under the trade name Trajenta in Europe.
The company said that the European Commission has approved linagliptin in combination with metformin and metformin plus sulfonylurea. 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.
In the U.S., linagliptin 5 mg is marketed under the trade name Tradjenta or linagliptin tablets and was approved by the U.S. Food and Drug Administration in May 2011 to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
The company said that 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).
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