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首页 » FDA信息 » 勃林格-礼来联盟向FDA重新提交糖尿病新药empagliflozin新药申请

勃林格-礼来联盟向FDA重新提交糖尿病新药empagliflozin新药申请

来源:生物谷 2014-06-18 13:40

2014年6月18讯 /生物谷BIOON/ --勃林格殷格翰-礼来糖尿病联盟6月17日宣布,已向FDA重新提交了实验性糖尿病药物empagliflozin的新药申请(NDA),寻求批准用于2型糖尿病(T2D)成人患者的治疗。1类(Class 1)重新提交遵循了FDA发布的一封完整回应函,该回应函引述了此前在勃林格殷格翰empagliflozin生产工厂发现的缺陷。FDA并没有要求勃林格殷格翰开展任何新的临床试验来支持empagliflozin的批准。Empagliflozin的临床项目是同类药物中最大的临床项目之一,包括10多个跨国临床试验,涉及超过1.3万例2型糖尿病患者。

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。

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2014年1月获FDA批准。

2014年3月,FDA因勃林格殷格翰一处empagliflozin生产工厂出现大颗粒污染事件,拒绝了勃林格-礼来糖尿病联盟empagliflozin的新药申请(NDA)。2014年6月,FDA根据3月份检查总结及充分考虑勃林格提交的支持性文档,确定勃林格药物生产工厂的质量管理及合规系统具有可接受性,撤回了此前发布的警告信。

2014年6月16日,勃林格-礼来糖尿病联盟在2014年第74届美国糖尿病协会科学大会(ADA2014)上公布了实验性糖尿病药物empagliflozin 2个III期临床试验的数据。在一项为期2年的研究中,将empagliflozin或格列美脲(glimepiride)添加至二甲双胍疗法,用于2型糖尿病(T2D)成人患者的治疗,数据表明,与格列美脲相比,empagliflozin使糖化血红蛋白(HA1c)实现了更大幅度的降低,体重及血压与格列美脲治疗组相当。另一项为期52周的研究,在高剂量胰岛素(有或无二甲双胍)仍无法充分控制血糖水平的T2D患者中开展,将empagliflozin或安慰剂添加至每日数次胰岛素注射疗法,数据表明,与安慰剂相比,empagliflozin显著降低了血糖水平和体重,同时降低了胰岛素剂量。研究中,empagliflozin的安全性与既往研究一致。(生物谷Bioon.com)

英文原文:Type 2 diabetes: Boehringer Ingelheim and Eli Lilly and Company announce resubmission of New Drug Application for empagliflozin to FDA

-- No additional clinical trials requested by the FDA

RIDGEFIELD, Conn. and INDIANAPOLIS, June 17, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes (T2D) to the U.S. Food and Drug Administration (FDA). The Class 1 resubmission follows a complete response letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

"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," said Paul Fonteyne, president and chief executive officer, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe in the potential of empagliflozin and hope to provide another treatment option in the near future to adults with type 2 diabetes."

Empagliflozin is an investigational SGLT2 inhibitor being studied for the reduction of blood glucose levels in adults with diabetes. The SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Empagliflozin was studied in one of the largest clinical trial programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 adults with type 2 diabetes.

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.

Boehringer Ingelheim and Eli Lilly and Company 
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

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