The US 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). 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, 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 US, was approved by the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Jardiance is not recommended for people with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs.
For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.