NDA for Empagliflozin Resubmitted to FDA
Boehringer Ingelheim and Eli Lilly and Company announced the resubmission of a New Drug Application (NDA) to the FDA for the empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of adults with type 2 diabetes.
The SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.
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.