Boehringer Ingelheim, Eli Lilly Receive FDA Complete Response Letter for Manufacturing Issues with Empagliflozin

Boehringer Ingelheim Pharmaceuticals Inc.and Eli Lilly and Company report that FDA has issued a complete response letter for the new drug application of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.

The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. FDA stated these deficiencies need to be resolved before the approval of the application. FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

“Boehringer Ingelheim and Lilly are committed to working with the FDA to make empagliflozin available to adults with Type 2 diabetes and submitting a response to the complete response letter as soon as possible,” according to an Eli Lilly press release.

Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.

In January 2011, Boehringer Ingelheim and Eli Lilly announced an alliance in the field of diabetes that centers on pipeline compounds representing several of the largest treatment classes.

Source: Eli Lilly and Company

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