一周打一针,中国长效降糖药孚来美®获批上市

2019-05-09 佚名 国家药监局 豪森药业 健康报社 医谷综合

5月7日,国家药品监督管理局通过优先审评审批程序批准1类创新药聚乙二醇洛塞那肽注射液(商品名:孚来美)上市,用于成人改善2型糖尿病患者的血糖控制。



5月7日,国家药品监督管理局通过优先审评审批程序批准1类创新药聚乙二醇洛塞那肽注射液(商品名:孚来美)上市,用于成人改善2型糖尿病患者的血糖控制。

聚乙二醇洛塞那肽是长效GLP-1受体激动剂,可促进葡萄糖依赖的胰岛素分泌,配合饮食控制和运动,单药或与二甲双胍联合,豪森药业官网显示,孚来美是中国首个自主创新的长效GLP-1受体激动剂,也是全球第一个PEG化的长效GLP-1受体激动剂。

我国作为糖尿病大国,患者人数1亿多,超过全球总患者数的四分之一,但国内GLP-1使用的规模还不到全球的1%!GLP-1受体激动剂凭借降糖效果强、副反应风险低等多重优势,已成为全球糖尿病市场主要的增长驱动,2018年销售93亿美元。

目前全球获批上市的GLP-1受体激动剂类降糖药有9款,其中有7款已在国内上市,有2款长效的GLP-1受体激动剂,分别是礼来的度拉糖肽和诺和诺德的索马鲁肽注射液,礼来的度拉糖肽目前处于临床在审评阶段,诺和诺德的索马鲁肽注射液已在2016年9月26日获批临床,两个药品皆为进口药品。此次本土药业豪森首获批,抢占国内长效GLP-1受体激动剂市场先机。

豪森药业官网表显示,孚来美每周仅需注射一次,显着提升了用药的便捷性,患者的依从性预期会显着提升,丰富了包括已通过一致性评价的孚来迪(瑞格列奈片)在内的糖尿病药物产品组合,预期将会给广大糖尿病患者带来更好的用药体验,为2型糖尿病患者提供新的治疗手段。

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    2020-03-02 weiz
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    2019-05-11 pyaili