BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes (T2D) to the U.S. Food and Drug Administration (FDA). 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 will be manufactured. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

"We are very pleased to move forward with resubmission of the empagliflozin NDA following a FDA inspection of the Boehringer Ingelheim facility referenced in the complete response letter," said Paul Fonteyne, president and chief executive officer, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe in the potential of empagliflozin and hope to provide another treatment option in the near future to adults with type 2 diabetes."

Empagliflozin is an investigational 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.