礼来的中和抗体bamlanivimab获得FDA紧急使用授权,用于治疗轻中度新冠COVID-19感染患者

2020-11-10 MedSci原创 MedSci原创

Bamlanivimab是靶向新冠病毒SARS-CoV-2的spike蛋白的中和抗体。

礼来公司的中和抗体bamlanivimab(LY-CoV555)获得FDA的紧急使用授权(EUA),用于治疗最新诊断的、12岁及以上的轻度至中度新冠病毒COVID-19感染患者,这些患者有发展为严重COVID-19/住院的高风险。

Bamlanivimab是靶向新冠病毒SARS-CoV-2的spike蛋白的中和抗体。

Clinical trials of monoclonal antibodies to prevent COVID-19 now enrolling  | National Institutes of Health (NIH)

图片来源:https://www.nih.gov/news-events/news-releases/clinical-trials-monoclonal-antibodies-prevent-covid-19-now-enrolling

FDA的决定是基于II期BLAZE-1研究的数据,初步研究表明bamlanivimab可降低新冠病毒载量、疾病症状和住院率。礼来公司首席科学官Daniel Skovronsky说,BLAZE-1数据表明:“ bamlanivimab在疾病早期进行干预,可能有助于患者清除病毒并减少COVID相关的住院。”

礼来(Lilly)指出,COVID-19测试阳性后的10天内,应尽快通过单次静脉输注bamlanivimab进行治疗。EUA包括超敏反应警告,包括过敏反应和与输注相关的反应。

礼来公司最近与美国政府签署了一份价值3.75亿美元的合同:将向美国政府提供30万瓶bamlanivimab用于新冠治疗。

原始出处:

https://www.firstwordpharma.com/node/1772678?tsid=4

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    2021-04-29 snf701207
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    2021-02-15 tamgche
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    2020-11-10 公卫新人

    新冠肺炎,疫情何时才能消失

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