EMA recommends Trajenta for approval

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Boehringer Ingelheim and Eli Lilly have received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of 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.

If adopted by the European Commission, linagliptin will be the only DPP-4 inhibitor approved at one dosage strength for patients with type 2 diabetes in Europe, according to the companies.

Linagliptin, 5 mg, is marketed under the trade name Tradjenta in the U.S. and was approved by the FDA in May 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.

EMA's Committee for Medicinal Products for Human Use has recommended the approval of linagliptin 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. Linagliptin also is recommended for approval in combination with metformin and metformin plus sulfonylurea.