FDA Accepts NDA for Type 2 Diabetes Combo Drug for Filing
Boehringer Ingelheim and Lilly announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for empagliflozin plus immediate-release metformin HCl fixed-dose combination for the treatment of adults with type 2 diabetes.
The NDA submission includes data from multiple clinical trials examining the co-administration of empagliflozin and metformin in the treatment of 4,740 adults with type 2 diabetes.
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 biguanide, decreases the production of glucose in the liver and its absorption in the intestine, and improves the body's ability to utilize glucose.Boehringer-Ingelheim.com or Lilly.com.