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首页 » 糖尿病 » FDA接受勃林格-礼来糖尿病新药empagliflozin/linagliptin新药申请

FDA接受勃林格-礼来糖尿病新药empagliflozin/linagliptin新药申请

来源:生物谷 2014-04-16 08:44

2014年4月16日讯 /生物谷BIOON/ --勃林格殷格翰-礼来糖尿病联盟4月14日联合宣布,FDA已接受实验性组合片剂empagliflozin/linagliptin新药申请(NDA),该药开发用于2型糖尿病(T2D)成人患者的治疗。

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,将过多的葡萄糖通过尿液排泄到体外,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。

linagliptin则属于二肽基肽酶-4(DPP-4)抑制剂类药物,可刺激刺激胰腺分泌更多的胰岛素,并刺激肝脏产生更少的葡萄糖。目前,linagliptin已在美国上市,品牌名为Tradjenta,作为每日一次的药物,结合饮食和运动改善2型糖尿病成人患者的血糖控制。

如果获批,empagliflozin/linagliptin组合片剂将成为首个将这2种具独特作用机制的药物合并至单一片剂的新药。(生物谷Bioon.com)

英文原文:Boehringer Ingelheim and Eli Lilly and Company Announce New Drug Application Filing in the U.S. for the Combination Tablet of Empagliflozin and Linagliptin

RIDGEFIELD, Conn. and INDIANAPOLIS, April 14, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application (NDA) for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with type 2 diabetes (T2D).

If granted approval by the FDA, this combination will bring together, for the first time into one tablet, the distinct mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor. SGLT2 inhibitors remove excess glucose through the urine by blocking glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

"The FDA acceptance of our filing for the combination tablet of empagliflozin and linagliptin brings us closer to providing patients with type 2 diabetes a potential treatment option that lowers blood sugar through the dual mechanism of action of a DPP-4 inhibitor and an SGLT2 inhibitor," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Adults living with type 2 diabetes often take more than one therapy to manage their condition, and we hope the combination of these two products will help them improve control of their blood sugar."

The filing follows the completion of a phase III clinical registration trial designed to evaluate the efficacy and safety of the empagliflozin/linagliptin combination compared to the individual components in adults with T2D. The Boehringer Ingelheim and Lilly Diabetes alliance plans to present data from this study later this year.

Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA has not been studied in patients with a history of pancreatitis.1

What are TRADJENTA tablets?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.

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