FDA授予RLF-100(Aviptadil)快速通道资格:治疗COVID-19呼吸窘迫

2020-06-25 Allan MedSci原创

制药公司NeuroRx近日宣布,美国FDA已授予研究性新药RLF-100(Aviptadil)快速通道资格,用以治疗与COVID-19相关的急性肺损伤/急性呼吸窘迫综合征。

制药公司NeuroRx近日宣布,美国FDA已授予研究性新药RLF-100(Aviptadil)快速通道资格,用以治疗与COVID-19相关的急性肺损伤/急性呼吸窘迫综合征。RLF-100是一款合成型人血管活性肠肽(VIP),可减少肺部炎症并保护II型肺泡细胞,这些细胞被认为是SARS-CoV-2侵袭肺部的途径。

作为NeuroRx加入快速通道计划的一部分,FDA已要求NeuroRx提交可公开获得的患者入组政策,以便患者可以进入RLF-100(Aviptadil)的III期临床试验。

在包括迈阿密大学、休斯敦卫理公会医院、加利福尼亚大学欧文分校、纽约大学朗格尼医学中心在内的主要医学中心,NeuroRx正在对RLF-100进行II/III期临床试验。这项多中心临床试验招募了重症COVID-19患者,这些患者存在呼吸衰竭。这些研究的目的旨在通过RLF-100拯救II型肺泡细胞来降低患者死亡率。

 

原始出处:

https://www.firstwordpharma.com/node/1735200

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    2020-10-30 chendoc254
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    2020-07-03 125619a9m67暂无昵称

    学到了

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    2020-06-25 医鸣惊人

    学习

    0

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