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FDA批准缓释艾塞那肽获准抗II型糖尿病

2012-02-06 MedSci MedSci原创

  1月27日,美国食品和药品监督管理局(FDA)批准了艾塞那肽注射液每周一次缓释剂型的上市申请,2型糖尿病(T2CD)成人在饮食和锻炼基础上,可使用此制剂改善血糖控制。   这是2型糖尿病治疗中的首个每周一次治疗药物。   研究表明,治疗24周,艾塞那肽缓释剂型可较基线降低糖化血红蛋白1.6%,而每日2次的剂型降低0.9%。该药最常见的不良反应是恶心、低血糖、呕吐、腹泻、紧张不安感、眩晕、头

  1月27日,美国食品和药品监督管理局(FDA)批准了艾塞那肽注射液每周一次缓释剂型的上市申请,2型糖尿病(T2CD)成人在饮食和锻炼基础上,可使用此制剂改善血糖控制。

  这是2型糖尿病治疗中的首个每周一次治疗药物。

  研究表明,治疗24周,艾塞那肽缓释剂型可较基线降低糖化血红蛋白1.6%,而每日2次的剂型降低0.9%。该药最常见的不良反应是恶心、低血糖、呕吐、腹泻、紧张不安感、眩晕、头痛、消化不良、便秘和无力。

  此项决定经过了2年半的观察和评估。不过,处于安全性考虑,在批准此剂型的同时,FDA要求制药厂(Amylin)进行一项随机、双盲、安慰剂对照的临床试验,评价该制剂对2型糖尿病患者主要不良心血管事件发生率的影响,同时也需要评估其他不良事件危险如胰腺癌、肾功能异常、严重低血糖,以及对甲状腺髓样癌(MTC)潜在生物标志物的长期影响。制药厂还被要求进行一系列动物实验。

  在药品批准书中还有另2项警示和要求,FDA要求制药厂建立一个MTC病例连续注册系统,用以监测至少15年的美国癌症年发生率,并鉴定任何与艾塞那肽缓释剂上市有关的癌症发生率的升高。制药厂还得制定一套危险评估和减轻策略(REMS),以确保药物的益处超过MTC和急性胰腺炎的危险。

  FDA对MTC的担心来自药物标签的黑框警告,该警告指出,艾塞那肽缓释剂在大鼠临床相关暴露中会引发包括MTC在内的甲状腺C细胞癌,临床和非临床研究不能确定其在人体中的相关性。黑框警告还指出,该药物在有个人或家族有MTC病史以及多发性内分泌肿瘤综合征患者中禁忌使用。

  链接:

  1、Once-Weekly Exenatide Okayed by FDA for T2DM After Long Look

  2、FDA NDA APPROVAL Letter

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    2015-09-27 tamil

    You got to push it-this esenitsal info that is!

    0

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    2012-09-26 bugit
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