FDA expands approval of Eli Lilly and Boehringer’s Tradjenta, for use with insulin

Hannah Blake

pharmaphorum

Following the first approval of generic versions of type 2 diabetes drug, Actos, the FDA has also approved updated prescribing information for Tradjenta tablets, for add-on therapy to insulin, in adults with type 2 diabetes.

Tradjenta (linagliptin) is a prescription medication used, along with diet and exercise, to lower blood sugar in adults with type 2 diabetes, developed by the Boehringer Ingelheim and Eli Lilly alliance formed in January 2011. Tradjenta can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes, such as metoformin, pioglitazone or insulin.

The FDA’s decision is based on data from a phase 3 trial, demonstrating the efficacy of Tradjenta in combination with insulin (with or without metformin and / or pioglitazone) over 52 weeks. The trial results showed that adding Tradjenta to insulin produced better glucose control than insulin alone.

Additionally, the FDA-approved label includes a clinical study in people with severe chronic renal impairment, which showed that the use of Tradjenta 5mg, plus other glucose-lowering therapies, provided a statistically significant improvement in glycated hemoglobin compared to placebo.

"Many people with type 2 diabetes taking insulin also require additional medication. With today's FDA decision, TRADJENTA can be an effective add-on therapy with a demonstrated safety profile to help adult patients on insulin to improve their blood sugar control. TRADJENTA is the only once-daily, one-dose drug in its class without the need for dose adjustment regardless of declining renal function or hepatic impairment."

John Smith, M.D., Ph.D., senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc.