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.

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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.

Jardiance (empagliflozin; Boehringer Ingelheim and Lilly) is already approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

For more information visit Boehringer-Ingelheim.com or Lilly.com.
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