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默沙东向日本药监局提交Omarigliptin治疗2型糖尿病的新药申请

2014-11-30 MedSci MedSci原创

omarigliptin糖尿病
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2014年11月24日，默沙东向日本药品和医疗器械管理局（PMDA）提交了降糖药omarigliptin的新药申请（NDA），omarigliptin是一种每周一次的DPP-4抑制剂，开发其用于2型糖尿病的治疗，业界预测，omarigliptin将成为默沙东在糖尿病市场投下的又一枚重磅炸弹。 此次提交该DPP-4抑制剂上市申请是基于一项在日本进行的3期研究，该研究在今年夏天举行的欧盟糖尿病研究协

2014年11月24日，默沙东向日本药品和医疗器械管理局（PMDA）提交了降糖药omarigliptin的新药申请（NDA），omarigliptin是一种每周一次的DPP-4抑制剂，开发其用于2型糖尿病的治疗，业界预测，omarigliptin将成为默沙东在糖尿病市场投下的又一枚重磅炸弹。

此次提交该DPP-4抑制剂上市申请是基于一项在日本进行的3期研究，该研究在今年夏天举行的欧盟糖尿病研究协会(EASD)会议上发布的。omarigliptin每周口服一次，而西他列汀每日口服一次，2者均属于二肽基肽酶IV（DPP-4）抑制剂，通过阻断DPP-4靶点发挥降糖作用。DPP-4抑制剂类降糖药具有全新的降血糖机制，同时具

有不增加体重、不会引起低血糖反应以及水肿等特点。

默沙东正对Omarigliptin全球范围内的9项3期试验进行相当大规模的投资，大约有7500名患者参与这些试验，该公司将在未来几个月内向美国及欧洲提交Omarigliptin的上市申请。


默沙东致力于糖尿病的研究，在其和与其他公司合作的基础上，默沙东致力于加强其在糖尿病领域的领导，提供广泛的产品组合，帮助2型糖尿病患者。

原始出处

Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes. November 24, 2014

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    2015-10-05 wangbingxhy

    #新药申请#

    0

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    2014-12-01 yese

    #默沙东#

    0

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    2014-12-01 chentianping

    #日本#

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    2014-12-01 xuyu

    #药监局#

    0

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近日，默沙东已向日本药品和医疗器械局（PMDA）提交了实验性降糖药omarigliptin的新药申请（NDA），标志着全球首个监管申请。 omarigliptin是一种每周一次的DPP-4抑制剂，开发用于2型糖尿病的治疗。在今年9月公布的首个III期临床中，omarigliptin疗效媲美默沙东自身热销的每日一次口服糖尿病药物Januvia（捷诺维，sitagliptin，西他列汀）。 Jan

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