Boehringer Ingelheim and Lilly receive CHMP backing for Trajenta

Boehringer Ingelheim and Lilly have received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval for a new indication of Trajenta.

The CHMP has issued a positive opinion on the expansion of Trajenta's licence to allow it to be used as an add-on therapy to insulin among adults with type 2 diabetes in Europe.

It would be used among patients receiving an insulin regimen with or without metformin when this treatment alone has not provided adequate glycaemic control, with phase III trial data supporting its efficacy in these cases.

The linagliptin-based Trajenta is described by Boehringer Ingelheim as the only diabetes therapy where a single dose can be appropriate for all patients.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "Linagliptin has a unique excretion pathway meaning no dose adjustment nor additional drug monitoring is required regardless of renal or hepatic function."

This comes after Boehringer Ingelheim last week applied for European approval of afatinib, a new therapy for lung cancer.