FDA Turns Down Boehringer And Lilly's Empagliflozin

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the companies’ New Drug Application (NDA) of empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor.

The FDA cited previously observed deficiencies at a facility owned by Boehringer Ingelheim where the drug will be manufactured. The federal watchdog said the defects need to be resolved before the application for empagliflozin can be approved. The FDA did not ask the companies to conduct or complete any additional clinical trials as supportive evidence and basis for the application’s approval.

Both companies declared they will continue working with the FDA to secure approval. “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,” the press release stated. The companies have also submitted a marketing authorization application to the European Medicines Agency about the same time it submitted the NDA to the FDA.

Diabetes is a chronic condition that occurs when the body loses the ability to properly produce or use the hormone insulin. The disease affects an estimated 24.4 million patients in the U.S. alone and approximately 382 million people around the world. Type 2 diabetes is more common than type 1 diabetes, accounting for 85 to 95% of all diabetes cases.

Empagliflozin belongs to sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds. The drug is being investigated for reduction of blood glucose levels in adults with Type 2 diabetes. Emerging sodium glucose co-transporter-2 (SGLT2) inhibitors work to remove glucose through the urine by inhibiting glucose re-absorption by the kidney.

The NDA for empagliflozin was based on a clinical registration programs in its class constituting of more than 10 multinational clinical trials and over 13,000 patients with Type 2 diabetes.