The EMA gave a positive opinion on Boehringer Ingelheim and Eli Lilly and Company’s linagliptin 5 mg film-coated tablets (trade name Trajenta®) for the treatment of type 2 diabetes in adults. Linagliptin is a DPP-4 inhibitor, and if approved, will be the only one of its kind in Europe to approved at one dosage strength.
Linagliptin as a monotherapy in patients with poorly controlled diet and with contradictions for the use of metformin, has been recommended by the Committee for Medicinal Products for Human Use (CHMP). It has also been recommended as a combination with metformin and metformin + sulphonylurea.
A clinical trial of 600 adults with type 2 diabetes included placebo-controlled studies evaluating linagliptin 5 mg as a monotherapy and in combination with commonly prescribed oral antihyperglycaemic medications. Results of the monotherapy studies showed a significant difference in HbA1c from placebo, as did the addition of linagliptin to patients on metformin or metformin plus sulphonylurea, who were not adequately controlled. In studies comparing the safety and efficacy of linagliptin compared to glimepiride, hypoglycaemia in the linagliptin group was significantly lower than that in the glimepiride group. Patients treated with glimepiride also showed significant weight gain.
“This will be an important step forward in the management of type 2 diabetes in Europe” said Prof. Anthony Barnett, Clinical Director, Department of Diabetes and Endocrinology, University of Birmingham and Heart of England NHS. “Studies show that linagliptin is efficacious with a favourable safety and tolerability profile. It is also primarily excreted unmetabolised via bile and gut, meaning no dose adjustment is needed in patients with declining kidney or liver function. Therefore, this will be the first DPP-4 inhibitor available at one dose for all patients”.