Monday , July 16 2018
Home / Resources / Articles / FDA Accepts Filing of NDA for Empagliflozin/Metformin Fixed-dose Combination

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

Oct 24, 2014

The single pill could help type 2 diabetes patients manage their blood sugar more effectively….

The U.S. Food and Drug Administration (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).

“Type 2 diabetes is a progressive condition, and many patients eventually require multiple medications to manage their blood sugar,” said Christophe Arbet-Engels, M.D., Ph.D., 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 utilize 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.

Empagliflozin, marketed as Jardiance (empagliflozin) tablets in the U.S., was approved by the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with T2D.

Practice Pearls:

  • anything?
  • at all?

FDA News Release, October 21