Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.
Empagliflozin is being investigated for the reduction of blood glucose levels in adults with type 2 diabetes (T2D). The SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.
The NDA submission was based on results from one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 people with type 2 diabetes. The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.