News Feature | October 24, 2014

Lilly, Boehringer Ingelheim NDA For Diabetes Combo Accepted By FDA

By Estel Grace Masangkay

Eli Lilly together with its partner Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for empagliflozin/metformin fixed-dose combination as treatment for Type 2 diabetes.

Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor that works to remove excess glucose from the blood through the urine. The drug does this by blocking glucose reabsorption in the kidney. Earlier this year, Lilly announced the European approval of empagliflozin, which is marketed as Jardiance. Metformin is a standard first-line treatment for T2D and works to lower the production of glucose in the liver. The drug is also used to decrease the absorption of glucose in the intestine as well as enhance the body’s ability to use blood sugar. The combination of empagliflozin and metformin is part of Lilly and BI’s diabetes alliance portfolio.

Dr. Christophe Arbet-Engels, VP of metabolic-clinical development and medical affairs at BI, said, “The FDA's acceptance of the NDA for the empagliflozin plus metformin fixed-dose combination brings us one step closer to offering a potential new treatment option that may help patients better manage their type 2 diabetes through one pill that combines two distinct approaches to help control blood sugar.”

The NDA for the combo diabetes therapy is supported by data from several clinical trials investigating the co-administration of empagliflozin and metformin in more than 4,700 patients with Type 2 diabetes.

An estimated 382 million people around the world are afflicted with either Type 1 or Type 2 diabetes, including 29 million people in the U.S. Almost 28 percent of diabetes patients in the U.S. are undiagnosed. Diabetes is a chronic condition that takes place when the body fails to either properly produce or use the hormone insulin. Type 2 diabetes is the most common type of diabetes, which is responsible for approximately 90 to 95 percent of all diabetes cases in the U.S.