Linagliptin recommended for approval in the treatment of type 2 diabetes in Europe
Ingelheim, Germany, 24 June, 2011 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today 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®) 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 type 2 diabetes patients in Europe.
The Committee for Medicinal Products for Human Use (CHMP) 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. 1 Linagliptin is also recommended for approval in combination with metformin and metformin + sulphonylurea. 1 Data shows that linagliptin reduces haemoglobin A1c (HbA1c) levels by a mean of -0.6 to -0.7 percent 2,3 (compared to placebo). HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. It is used as a marker to determine the efficacy of glucose-lowering therapies.