Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Company said they have resubmitted a New Drug Application for the investigational Type 2 diabetes treatment empagliflozin.
The Class 1 resubmission follows a complete response letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin would be manufactured. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.
Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for the reduction of blood glucose levels in adults with diabetes. The SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Empagliflozin was studied in one of the largest clinical trial programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 adults with Type 2 diabetes.