BI And Lilly To Resubmit Empagliflozin NDA To FDA

Boehringer Ingelheim and Eli Lilly & Co. announced that the companies are resubmitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin as treatment for adults with type 2 diabetes.

Empagliflozin is an investigational SGLT2 inhibitor under study for the reduction of blood sugar levels in adult T2D patients. The drug belongs to the SGLT2 inhibitor class which works to remove excess blood glucose through the urine by inhibiting glucose re-absorption in the kidney.

The companies’ initial NDA submission for empagliflozin was met with a complete response letter (CRL) from the FDA due to previously observed deficiencies at a Boehringer Ingelheim manufacturing facility where the drug was produced. No additional clinical trials were requested by the FDA for the Class 1 resubmission.

Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, said, “We are very pleased to move forward with resubmission of the empagliflozin NDA following a FDA inspection of the Boehringer Ingelheim facility referenced in the complete response letter. We believe in the potential of empagliflozin and hope to provide another treatment option in the near future to adults with type 2 diabetes.”

Around 24.4 million patients in the U.S. suffer from type 1 and type 2 diabetes. Type 2 diabetes is the leading type of diabetes, accounting for about 85 to 95 percent of all cases.

Earlier this June Eli Lilly reported positive results from a two year study investigating empagliflozin as an add-on therapy to metformin. Trial data showed that the drug demonstrated meaningfully greater decreases in blood glucose, body weight, and blood pressure compared to glimepiride as add-on to metformin. Empagliflozin added to multiple daily insulin injections also significantly reduced blood glucose and body weight with lower insulin doses compared with placebo in a 52-week study.

Eli Lilly and Boehringer Ingelheim’s alliance in diabetes started in January 2011, when the partners agreed to co-develop compounds representing some of the largest diabetes treatment classes.