勃林格-礼来糖尿病新药empagliflozin遭FDA拒绝

关键词:礼来,勃林格殷格翰,empagliflozin,SGLT2抑制剂,糖尿病

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。

FDA提及的问题出自勃林格位于莱茵河畔的工厂。去年春天,FDA发出了一封警告信,责骂勃林格未能尽职调查该工厂生产的数个批次活性药物成分中出现大颗粒污染事件。当时,勃林格表示,将认真对待FDA的警告,但同时称,该工厂在过去5年里已通过了22次检查。

此次empagliflozin遭拒,也给礼来带来了不小的麻烦,该公司已发誓今年要收获“几个”新药审批,以弥补对新药批文的长久缺憾。如果empagliflozin被FDA无限期搁置,礼来在今年所能指望的可能只剩GLP-1糖尿病药物dulaglutide和抗癌药ramucirumab了,目前这2个药物已积累了庞大的积极III期数据。

同时,此次遭拒也是继几周前礼来开发的来得时(Lantus)仿制药被搁置之后的最新打击。此前,赛诺菲起诉了礼来,称礼来侵犯了其4个专利。而这场法律拌嘴,很可能会推迟礼来Lantus仿制药的上市,直到2016年中期。

另外,empagliflozin仍然代表着礼来同其他制药公司SGLT-2抑制剂类药物抗衡的最佳人选,如强生的Invokana、阿斯利康和百时美施贵宝的Farxiga(dapagliflozin)。Invokana于2013年11月获FDA批准,Farxiga则在经历长期审查推迟后也最终于今年1月获FDA批准。

Empagliflozin属于钠-葡萄糖协同转运蛋白-2(SGLT-2)抑制剂类药物,目前正调查用于2型糖尿病成人患者的治疗。新兴的SGLT-2抑制剂类药物,已被证实能够阻断肾脏中葡萄糖的再吸收作用,将过多的葡萄糖排泄到体外,从而达到降低血糖水平的效果,而且该降糖效果不依赖于β细胞功能和胰岛素抵抗。(生物谷Bioon.com)

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).

About Diabetes

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.

(责任编辑:lishuheng)

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