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Lilly和Boehringer Ingelheim为Empagliflozin提交了新的药物应用程序

发布时间:4/30/13
7.读者推荐

3月25日,Lilly和Boehringer Ingelheim(BI)宣布他们向Empagliflozin的FDA提交了SGRT-2抑制剂的FDA,适用于2型糖尿病。这种药物与janssen的Invokana(蜜月)的课程相同,这是最近被FDA批准现在可以在美国提供(见www.invokana.com.)。1月份早些时候,Lilly / Bi宣布了四个已完成的Empagliflozin研究的正面结果。The drug significantly reduced A1c – we’re still waiting to find out from Lilly/BI the phase 3 trial full results – and had an acceptable safety profile, though the drug has increased rates of genital infections compared to placebo as other SGLT-2 inhibitors do. By the time Lilly/BI finishes the phase 3 program, the company will have results from 14,500 participants from eight different countries. Some of the more interesting trials tested empagliflozin in combination with other diabetes medications. For instance, empagliflozin was combined with Lilly/BI’sTradjenta.(Linagliptin),aDPP-4抑制剂。DPP-4抑制剂具有低血糖风险的血糖水平降低,低血糖风险低,并且重量中性。具有Empagliflozin的组合药物可具有有效的血糖降低效果,而无需低血糖风险。FDA通常需要一年的待审查药物,意思是Empagliflozin可以于2014年3月批准。请阅读我们的学习曲线在这个新的药物课上,更多关于SGLT-2抑制剂。-mn.

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