FDA approves Eli Lilly, Boehringer Ingelheim's Tradjenta for diabetes

The FDA announced on Monday that it approved Eli Lilly and Boehringer Ingelheim's oral, once-daily drug Tradjenta (linagliptin) as a treatment for adults with type 2 diabetes.

The approval of the DPP-4 inhibitor was based on data from eight clinical trials involving approximately 3800 patients with type 2 diabetes that demonstrated that the companies' experimental product improved blood glucose control compared with placebo. The agency noted that Tradjenta had been studied both as a stand-alone therapy and in combination with other diabetes therapies including metformin, glimepiride, and pioglitazone.

Tradjenta is one of several diabetes drugs being developed under a co-development agreement reached between Eli Lilly and Boehringer Ingelheim in January.

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