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Boehringer Ingelheim And Eli Lilly And Co Submit New Drug Application To FDA For Empagliflozin


Monday, 25 Mar 2013 08:00am EDT 

Boehringer Ingelheim and Eli Lilly And Co 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. 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. 

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