G-BA rebuffs Pixuvri, Trajenta for second indication

Germany's Federal Joint Committee (G-BA) issued a final benefit assessment rebuffing diabetes drug Trajenta linagliptin from Boehringer Ingelheim GmbH (Ingelheim, Germany) as add-on therapy to insulin with or without metformin to treat Type II diabetes -- an indication approved by the European Commission last year. G-BA said the xanthine-based dipeptidyl peptidase-4 (DPP-4) as add-on therapy to insulin provides "no additional benefit" over human insulin and metformin, G-BA's requested comparator, because the company did not submit "necessary evidence." The decision is in line with a preliminary assessment G-BA issued in March (see BioCentury, March 18).

Boehringer and partner Eli Lilly and Co. (NYSE:LLY) do not market Trajenta in Germany. ...