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RIDGEFIELD, Conn., and INDIANAPOLIS — Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. have been cleared by the Food and Drug Administration to market Tradjenta tablets, a treatment for type 2 diabetes.
The companies said Monday that the Tradjenta (linagliptin) approval marks the first regulatory milestone since they formed a global diabetes alliance in January. The partnership leverages the collective scientific expertise and business capabilities of the pharmaceutical firms to address patient needs arising from the burgeoning diabetes epidemic.
Tradjenta is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The prescription medication can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in hemoglobin A1C levels up to 0.7%, according to the companies.
"Many people with type 2 diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications," stated John Gerich, professor of medicine at University of Rochester School of Medicine. "The FDA approval of Tradjenta is exciting because there is only one dose to remember for all patients, regardless of kidney or liver impairment. With Tradjenta, physicians will have another option for managing type 2 diabetes, a potentially devastating condition."
An estimated 25.8 million Americans and 220 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common and represents about 95% of all diabetes cases.
"Type 2 diabetes is increasing at an alarming rate, and we are proud to offer a new treatment option that could potentially help the millions of people with type 2 diabetes whose blood sugar is uncontrolled," Albert Ros, president and chief executive officer of Boehringer Ingelheim Pharmaceuticals, said in a statement.
Enrique Conterno, president of Lilly Diabetes, commented, "Our alliance with Boehringer Ingelheim represents one of the most robust diabetes pipelines in the pharmaceutical industry. Tradjenta is the first regulatory approval of what we hope will be many new treatment options this alliance brings to the millions of Americans living with type 2 diabetes."
