Boehringer Ingelheim and Eli Lilly and Company’s DPP-4 inhibitor received positive feedback from the European Medicines Agency’s (EMA) medicinal committee recommending approval of linagliptin, 5 mg, film-coated tablets for 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. Linagliptin is marketed under the trade name Tradjenta (linagliptin) tablets in the U.S. 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).
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. Linagliptin is also recommended for approval in combination with metformin and metformin plus sulfonylurea.
“Linagliptin is primarily excreted via the bile and gut, meaning no dose adjustment is recommended in patients with kidney or liver impairment. Therefore, this will be the first DPP-4 inhibitor available at one dose for all adult patients with type 2 diabetes,” says professor Anthony Barnett, clinical director, department of Diabetes and Endocrinology, University of Birmingham and Heart of England, NHS.
Linagliptin received a positive opinion based on a clinical trial program which involved approximately 4,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating linagliptin as monotherapy and in combination with the commonly prescribed oral antihyperglycemic medications, metformin and/or sulfonylurea.
Release Date: June 23, 2011
Source: Boehringer Ingelheim
Filed Under: Drug Discovery