FDA Issues Complete Response Letter for Empagliflo?zin

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company have announced the 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. FDA stated these deficiencies need to be resolved before the approval of the application. 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 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 US NDA was based on results from one of the largest clinical registration programmes in its class, comprised of more than 10 multinational clinical trials and more than 13,000 people with type 2 diabetes (T2D).

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com