2014年3月6日讯 /生物谷BIOON/ --勃林格殷格翰-礼来糖尿病联盟降糖新药empagliflozin遭FDA拒绝。该联盟3月5日称，FDA已就empagliflozin的新药申请（NDA）发布了一封完整回应函（CRL）。在函中，FDA提及了此前在勃林格殷格翰生产empagliflozin的工厂里发现的缺陷。FDA指出，这些问题需要在empagliflozin NDA获批之前解决。不过FDA并没有要求开展任何新的临床试验来支持empagliflozin NDA的批准。该联盟称，将尽快提交对完整回应函的回应，同时将与FDA密切合作，使empagliflozin尽早获批上市，造福2型糖尿病患者。
英文原文：FDA rejects Eli Lilly's SGLT2 diabetes drug empagliflozin
RIDGEFIELD, Conn. and INDIANAPOLIS, March 5, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (Lilly; NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) 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. The FDA stated these deficiencies need to be resolved before the approval of the application. The 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.
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.
The U.S. NDA 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 (T2D).
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.1
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.