Boehringer Ingelheim and Eli Lilly Submit NDA for Empagliflozin
Boehringer Ingelheim and Eli Lilly and Company announced that a New Drug Application (NDA) was submitted to the FDA for empagliflozin for the treatment of type 2 diabetes mellitus (T2D) in adults. Empagliflozin is a member of the sodium glucose co-transporter-2 (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 3 clinical trial program that plans to enroll more than 14,500 patients. There are a total of 12 multinational clinical trials in this program, including a large cardiovascular outcome trial.