Empagliflozin is re-submitted to FDA for Type 2 Diabetes- Eli Lilly/Boehringer

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company 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 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.

The resubmission (which would give a PDUFA date of 17 August, a Sunday, means approval would be likely on the Friday before).