The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin.
Boehringer Ingelheim Pharmaceuticals clinical development and medical affairs senior vice president John Smith said with 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," Smith added.
Tradjenta is used to lower blood sugar in adults with type 2 diabetes and can also be used as monotherapy or in combination with other medications to treat type 2 diabetes such as metformin, sulfonylurea, pioglitazone or insulin.
FDA has approved Tradjenta based on data from a 52-week, phase 3 trial that demonstrated the efficacy of Tradjenta in combination with insulin.
