Added benefit of Trajenta not proven, says German agency

In an early benefit assessment under Germany’s "Act on the Reform of the Market for Medicinal Products” (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether German family-owned drug major Boehringer Ingelheim and USA-based Eli Lilly’s (NYSE: LLY) diabetes drug Trajenta (linagliptin) offers an added benefit versus the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). No such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the G-BA's specifications and chose a different comparator therapy, the IQWiG concluded.

Trajenta has been approved in Europe since last summer to improve blood glucose control (glycemic control) in adults with type 2 diabetes mellitus whose elevated blood glucose levels are inadequately controlled by diet and exercise (The Pharma Letter August 26, 2011). The drug has also been cleared in the USA where it carries the trade name Tradjenta (TPL May 4, 2011). It is an option for patients who do not tolerate or should not take the usual treatment with the drug metformin. Moreover, linagliptin can be added if treatment with metformin alone is not sufficient.

Approval status distinguishes between three treatment situations