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Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment
Date:3/25/2013

RIDGEFIELD, Conn. and INDIANAPOLIS, March 25, 2013 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin* was recently submitted to the Food and Drug Administration (FDA) in the United States for the treatment of type 2 diabetes mellitus (T2D) in adults.

Empagliflozin is a member of the SGLT2 inhibitor class of drugs 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.

"We are excited to have submitted an application for a potential new treatment option that may help patients better manage their type 2 diabetes mellitus," said Christophe Arbet-Engels , MD, PhD, MBA, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim. "Type 2 diabetes mellitus is a critical health issue facing the world today, and through the Boehringer Ingelheim and Lilly Diabetes Alliance, we are committed to developing new treatments to address patients with this disease."

Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial program that plans to enroll more than 14,500 patients.[1] In total, this program comprises 12 multinational clinical trials, including a large cardiovascular outcome trial. Boehringer Ingelheim and Lilly plan to present detailed data disclosures for many of these studies at scientific medical meetings and in publications in 2013 and 2014.

About Diabetes 
Approximately 25.8 million Americans[2] and an estimated 371 million people worldwide[3] have type 1 or ty
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
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