FDA专家组12:11支持SGLT2抑制剂Jardiance标签扩展

2016-07-04 佚名美中药源

昨天FDA内分泌与代谢药物专家组以12票支持、11反对的微弱优势支持礼来和BI的SGLT2抑制剂Jardiance降低心血管死亡的标签扩展。FDA将在今年9月做出最后裁决。现在所有的糖尿病药物都是根据降糖疗效批准。自2007年Avandia事件后所有新药要显示可以安全降糖，即没有心血管副作用。去年一个叫做EMPA-REG的四期临床试验显示使用3年Jardiance可以降低38%的心脏病死亡

昨天FDA内分泌与代谢药物专家组以12票支持、11反对的微弱优势支持礼来和BI的SGLT2抑制剂Jardiance降低心血管死亡的标签扩展。FDA将在今年9月做出最后裁决。

现在所有的糖尿病药物都是根据降糖疗效批准。自2007年Avandia事件后所有新药要显示可以安全降糖，即没有心血管副作用。去年一个叫做EMPA-REG的四期临床试验显示使用3年Jardiance可以降低38%的心脏病死亡率，32%全因死亡率，成为第一个显示心血管收益的降糖药。今年ADA年会上礼来报道这个试验也显示Jardiance能延缓肾功能障碍恶化速度。后来GLP激动剂也显示有心血管收益，为血糖毒性假说增加一些证据。

EMPA-REG本来是个安全性试验，但Jardiance作为第三个进入SGLT领域的药物必须要显示一定区分，所以礼来和BI中途将该试验扩展为疗效试验。默沙东和辉瑞的同类药物Ertugliflozin也在今年采取了同样策略，将安全性试验入组病人人数加倍到8000人扩展为疗效试验。改善血液指标作为疾病治疗代替物已经越来越难以获得药监和支付部门认同，连LDL这个研究最充分的指标现在也无法代替疾病改善。昨天FDA告知Esperion的降脂药ETC-1002需要有CVOT结果才能上市，而辉瑞虽然在PCSK9竞争中起步较晚但因CVOT开始最早，所以bococizumab仍然会成为PCSK9市场的有力竞争者。

一般FDA慢性病药物标签至少要有两个大型三期临床试验的支持，这也是专家组有大量反对声音的主要原因。Jardiance作为第一个改善心血管预后的降糖药更是要面对比成熟机制更多的质疑。EMPA-REG的一级终点是三个指标的组合，但Jardiance对其它两个指标心梗和中风无显着影响，这也令一些专家有所怀疑。还有一些细节如7020病人中有230位病人提前揭盲、210位病人中途退出试验、124位死亡病人死因没有记录等，也增加了数据分析的难度。强生同类药物的CVOT试验结果将于明年公布，如果阳性将令EMPA-REG的结论更加可信。

但是即便有这些不确定因素，Jardiance仍然和其它降糖药有本质却别，因为除了GLP激动剂没有其它降糖药显示过心血管收益。所以有专家认为心血管收益写不写进标签影响有限，因为这个信息已经广泛传播。现在估计Jardiance年销售到2020年将达到30亿美元，成为礼来的最主要产品之一。Jardiance和辉瑞PCSK9抑制剂bococizumab的经验值得现在诸多PD-1厂家借鉴。重复首创药物的疗效不足以参与竞争，必须要找到足够的区分。

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2017-04-01 more is better!

#专家组#

83 0
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2016-07-22 tulenzi

#SGLT#

68 0
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2016-07-30 ms9608593228839890

#DIA#

66 0
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2017-01-26 仁医06

#2抑制剂#

66 0
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2016-09-12 jklm09

#抑制剂#

62 0
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2016-09-21 1e10c84am36(暂无匿称)

文章很好，非常有益

129 0
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2016-09-13 舒心和人

新药上市后经过大规模临床试验就能显示真正的效果，就像二甲双胍，经久不衰，历久弥新

134 0
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2016-07-05 jiekemin

#SGLT2#

67 0
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2016-07-05 lq1773

#Jardiance#

72 0

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