Boehringer Ingelheim and Lilly receive EU backing for diabetes drug

Boehringer Ingelheim and Lilly have been granted a positive opinion for approval of their new type 2 diabetes drug linagliptin in Europe.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the treatment as a monotherapy among patients whose conditions are inadequately controlled by diet and exercise alone and who are unable to benefit from metformin.

Its decision was based on positive safety and efficacy data from a number of pivotal clinical trials, showing its benefits compared to both placebo and alternative treatments.

If ratified, it would be sold under the name Trajenta and would be the only DPP-4 inhibitor approved at one dosage strength for type 2 diabetes patients in Europe.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "We are proud that we may soon have the opportunity to offer a new treatment option … to the millions of European patients with type 2 diabetes whose blood glucose is not adequately controlled."

Boehringer Ingelheim and Lilly have been collaborating in the field of diabetes since January 2011 and are jointly presenting new clinical data at the American Diabetes Association Scientific Sessions this week.