Boehringer and Eli Lilly submit NDA to the FDA for empagliflozin for treatment of Type 2 Diabetes
Boehringer Ingelheim and Eli Lilly and Company have announced that a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin was recently submitted to the FDA 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. 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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