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NDA Submitted for Investigational Diabetes Drug, Empagliflozin

Marketing application follows completion of phase III registration trials (Mar. 25)

A new drug application (NDA) has been submitted to the FDA for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin (Boehringer Ingelheim/Eli Lilly) for the treatment of type 2 diabetes mellitus (T2D) in adults.

Empagliflozin is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.

The phase III clinical trial program for empagliflozin plans to enroll more than 14,500 patients with T2D in 12 multinational clinical trials, including a large cardiovascular outcomes study.

Approximately 25.8 million people in the U.S. and an estimated 371 million people worldwide have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 90% of all diabetes cases. In 2012, diabetes was estimated to cost the U.S. $245 billion in direct medical costs and reduced productivity.

Source: Eli Lilly; March 25, 2013.

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