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美国FDA拒绝了双重SGLT1和SGLT2抑制剂Zynquista治疗1型糖尿病的申请

2019-03-24 不详 网络

赛诺菲和Lexicon制药公司周五(2019年3月23日)宣布,FDA已拒绝其双重SGLT1和SGLT2抑制剂Zynquista(sotagliflozin)合并胰岛素用于治疗成人1型糖尿病的申请。

赛诺菲和Lexicon制药公司周五(2019323日)宣布,FDA已拒绝其双重SGLT1SGLT2抑制剂Zynquistasotagliflozin)合并胰岛素用于治疗成人1糖尿病的申请。

20191月份,FDA顾问小组对是否支持Zynquista的批准存在分歧,而机构工作人员对使用该药物治疗的患者中糖尿病酮酸中毒风险较高且可能具有无法预测的风险表示担忧。但2017年的III期试验表明,Zynquista的治疗没有导致严重低血糖糖尿病酮酸中毒的发作,Zynquista还在Tandem1Tandem2试验中达到III期试验的主要终点。


原始出处:

http://www.firstwordpharma.com/node/1630997?tsid=4#axzz5j31eEshK

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    2019-03-30 tulenzi
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    2019-12-12 licz0423
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    2019-07-07 jklm09
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    2019-03-26 jiekemin
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    2019-03-24 misszhang

    谢谢MedSci提供最新的资讯

    0

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