FDA解除批评警告，恩格列净将重新提交

2014年6月4日讯 --勃林格殷格翰（Boehringer Ingelheim）6月3日宣布，FDA于6月2日发信告知已关闭此前发布的警告信。该警告信与勃林格殷格翰的一家药物工厂的生产问题有关。

在信中，FDA称，根据3月份的检查总结及充分考虑勃林格提交的支持性文档，已确定该公司莱茵河畔药物生产工厂的质量管理及合规系统是可以接受的。

去年春天，FDA发出了一封警告信，批评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。今年3月，FDA据此理由拒绝批准勃林格殷格翰-礼来糖尿病联盟降糖新药864070-44-0 艾格列净。此次遭拒，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。

此次FDA解除警告信，也为勃林格殷翰姆与礼来的糖尿病联盟再次提交864070-44-0 艾格列净新药申请（NDA）扫清了道路。

864070-44-0 艾格列净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，如强生的卡格列净、阿斯利康和百时美施贵宝的达格列净（dapagliflozin）。卡格列净于2013年11月获FDA批准，达格列净则在经历长期审查推迟后也最终于今年1月获FDA批准。

864070-44-0 艾格列净属于钠-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：Boehringer fixes factory, clearing way for new approval request

(Reuters) - Eli Lilly's partner in a diabetes alliance, Boehringer Ingelheim, said that U.S. regulators had given it the go-ahead for a German plant after solving quality problems, paving the way for a renewed request for approval of a drug.

The U.S. Food and Drug Administration in March declined to approve Lilly and Boehringer's experimental diabetes drug empagliflozin, citing manufacturing problems at Boehringer's headquarters, where it would be made.

Boehringer on Tuesday said it was told by the FDA that based on a March inspection, the facility's quality management and compliance systems were found to be acceptable again.

"This gives us the opportunity to renew our request for approval," a company spokesman said.

The drug is a member of a new class of diabetes medicines known as SGLT2 inhibitors, which block the kidney from reabsorbing blood sugar, thereby spurring removal of glucose through the urine. Recently approved similar medicines include Johnson & Johnson's Invokana.

Analysts surveyed by Thomson Reuters Cortellis on average expect Lilly to generate sales of more than $400 million from the drug in 2019.

The FDA issued a warning letter in May 2013 citing problems it found at the Boehringer plant during an inspection six months earlier. Among other issues, the FDA said it detected foreign particles in batches of active pharmaceutical ingredients.