European regulators have approved a new indication for Boehringer Ingelheim and Lilly's Trajenta (linagliptin) that will allow it to be used in combination with insulin to treat adults with type 2 diabetes.
The approval means Trajenta is now indicated for use in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
This brings it into line with its fellow dipeptidyl peptidase-4 (DPP-4) inhibitors AstraZeneca and BMS' Onglyza (saxagliptin) and Januvia (sitagliptin), Merck & Co's sector-leading drug.
Prof Klaus Dugi, corporate senior vice president medicine at Boehringer Ingelheim, said: “We are delighted that approval has been granted for the use of linagliptin as an add-on to insulin in adults with type 2 diabetes.
“This expanded indication shows that linagliptin is an effective treatment for patients at various stages of type 2 diabetes.”
Trajenta's latest approval was based on trials showing that after 24 weeks, adding the drug to insulin produced better glucose control than insulin alone, without an additional risk of hypoglycaemia.
Trajenta is the lead product in the diabetes alliance Boehringer and Lilly formed last year and the drug was first approved in Europe last August in combination with metformin and metformin plus sulphonylurea. It also has a licence as a monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate.
Trajenta works by increasing the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 (DPP-4).
Although not the first of the DPP-4 inhibitors to be approved, it is the first to be licensed at one dosage strength (5 mg, once daily), with no dose adjustment necessary in patients with kidney or liver impairment.
Boehringer and Lilly will be hoping to build on this advantage with their follow-up product Jentadueto, which combines Trajenta's active ingredient linagliptin with metformin and was approved in Europe over the summer.