Boehringer Ingelheim and Eli Lilly and Company today announced that they have received a Positive Opinion from the European Medicines Agency’s (EMA) medicinal committee recommending expanding the therapeutic indication for the DPP-4 inhibitor Trajenta® (linagliptin). If approved by the European Commission, this will expand the indicated use of Trajenta® by the combination with insulin in adults with Type 2 Diabetes.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of linagliptin in combination with insulin with or without metformin, when this regimen alone, with diet and exercise does not provide adequate glycaemic control. The CHMP’s Positive Opinion is based on data from a number of clinical studies, including efficacy data from a phase III trial of at least 52 weeks duration demonstrating the efficacy and safety of linagliptin in combination with basal insulin (primary endpoint: efficacy after 24 weeks). The trial results showed that after 24 weeks, adding linagliptin to insulin produced better glucose control than insulin alone, without an additional risk of hypoglycaemia.(1)
“Many patients with Type 2 Diabetes taking insulin require additional medication for adequate blood glucose control. This CHMP positive opinion is an important step towards offering further treatment options to those with Type 2 Diabetes,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Linagliptin is the first diabetes treatment in which one dose is the right dose for all patients. Linagliptin has a unique excretion pathway meaning no dose adjustment nor additional drug monitoring is required regardless of renal or hepatic function. ”
Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase-4) which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homoeostasis.(2)
Linagliptin (5 mg, once-daily) is marketed as Trajenta® across Europe and Canada, as Tradjenta™ in the US, and Trazenta® in Japan, as well as in additional markets.(2,3)
Linagliptin is a prescription medicine that is used along with diet and exercise to lower blood glucose in adults with Type 2 Diabetes.(2,3) Linagliptin is not for people with Type 1 Diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).(2,3)
- Boehringer Ingelheim. Data on File
- Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002110/WC500115745.pdf
- Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011.