Boehringer and Lilly re-file empagliflozin NDA with FDA

The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly (NYSE: LLY) have resubmitted a New Drug Application for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes to the US Food and Drug Administration.

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.

Drug already approved in Europe