U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced March 5 the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.
The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies need to be resolved before the approval of the application. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application. Boehringer Ingelheim and Lilly are committed to working with the FDA to make empagliflozin available to adults with type 2 diabetes and submitting a response to the complete response letter as soon as possible.
Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, and is 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 by the kidney. The U.S. NDA was based on results from one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 people with type 2 diabetes (T2D).
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.