FDA Accepts Filing of NDA for Empagliflozin/Metformin Fixed-Dose Combination

FDA has accepted the filing of a New Drug Application (NDA) for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes (T2D). Empagliflozin plus metformin is part of the Boehringer Ingelheim and Eli Lilly and Company Diabetes alliance portfolio.

"Type 2 diabetes is a progressive condition, and  many patients eventually require multiple medications to manage their blood sugar," said Christophe Arbet-Engels,Vice President, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "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."

Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor, which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilise glucose.

The filing includes data from multiple clinical trials examining the co-administration of empagliflozin and metformin in the treatment of 4,740 adults with T2D.