Boehringer Ingelheim, Eli Lilly Resubmit NDA for Diabetes Drug

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company have 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 to the US 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. 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.

The drug was developed as part of the diabetes alliance between Boehringer Ingelheim and Eli Lilly, which was formed in January 2011.

Source: Eli Lilly

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