美国FDA专家组一致同意Shire的普卢卡必利治疗慢性特发性便秘

2018-10-21 MedSci MedSci原创

Shire制药公司近日宣布,FDA咨询委员会投票一致称,Shire的普卢卡必利的风险-收益情况良好,支持批准普卢卡必利治疗成人慢性特发性便秘(CIC)。FDA将于12月21日前对营销申请作出最终决定。

Shire制药公司近日宣布,FDA咨询委员会投票一致称,Shire的普卢卡必利的风险-收益情况良好,支持批准普卢卡必利治疗成人慢性特发性便秘(CIC)。FDA将于1221日前对营销申请作出最终决定。

Shire指出,FDA咨询委员会还一致投票表示,其他类似于普卢卡必利的药物(血清素4型受体激动剂),先前已与不良血管CV)事件相关,但是普卢卡必利治疗成人CIC时不会导致血管不良事件。咨询委员会在审查了六项关键性研究的数据后做出了支持决定,这些试验包括五项主要的III期试验。结果显示,在12周治疗期间,在使用普卢卡必利治疗的患者中,27.8%的患者每周平均三次或更多次自发完全排便,而安慰剂组仅为13.2%。FDA咨询委员会还评估了一项安全性研究的结果,该研究检测了普卢卡必利的主要不良心血管事件(MACE)发生率。


原始出处:

http://www.firstwordpharma.com/node/1598467#axzz5UXJIsme7

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    2019-01-21 liuli5088
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