欧盟批准血管紧张素II(Giapreza)治疗难治性低血压

2019-09-01 不详 MedSci原创

La Jolla制药公司宣布,欧盟委员会(EC)已批准Giapreza(血管紧张素II)用于治疗患有脓毒性或其他分布性休克的难治性低血压成人患者。该适应症适用于应用儿茶酚胺和其他血管加压药治疗有足够的体积恢复但仍保持低血压的患者。

La Jolla制药公司宣布,欧盟委员会(EC)已批准Giapreza(血管紧张素II)用于治疗患有脓毒性或其他分布性休克的难治性低血压成人患者。该适应症适用于应用儿茶酚胺和其他血管加压药治疗有足够的体积恢复但仍保持低血压的患者。

该批准基于ATHOS-3(血管紧张素II治疗高输出休克)III期研究的数据,该研究证明了该药物对脓毒性或其他分布性休克患者的安全性和有效性。

7月,欧洲药品管理局(EMA)人用药品委员会(CHMP)批准了该药物的上市许可,用于治疗脓毒性或其他分布性休克的成人难治性低血压。

该药物通过模仿人体内源性调节肽发挥作用,该调节肽是肾素-血管紧张素-醛固酮系统的核心,可增加血压。

2017年12月,它被美国食品和药物管理局(FDA)批准为血管收缩剂,用于增加患有脓毒性或其他分布性休克成人的血压。

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    2019-09-03 freve
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    2019-09-02 thm112988

    0

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