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FDA允许紧急使用特朗普使用过的抗体药物

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除了康瑞疫苗开始申请紧急授权外,食品和药物管理局(FDA)于2020年11月21日还授权使用Regeneron Pharmaceuticals Inc.的药物,以防止轻度至中度疾病的患者恶化并需要住院治疗,以帮助免疫系统对抗COVID-19。抗体是身体制造的蛋白质,以瞄准并帮助消除病毒,但在感染发生后,最好的抗体可能需要数周才能形成。

这也是特朗普感染新冠进行治疗时用过的一种实验性药物。但是,由于大多数COVID-19患者都能自行康复,以及特朗普的康复是因为接受过一系列治疗,所以现在还无法确定是否一定是Regeneron药物帮助特朗普恢复的。

这种药物是通过静脉注射的一次性治疗(允许其在成人和12岁及以上的儿童体重至少88磅/40公斤),但是目前仍在经历更多的测试,以确定其安全性和有效性。

Regeneron表示,初始剂量将通过联邦政府的分配计划提供给大约30万名患者。这些患者不会被收取药物费用,但可能需要支付部分静脉注射的费用。

The Food and Drug Administration on Saturday, Nov. 21, 2020 authorized the use of the Regeneron Pharmaceuticals Inc. drug to try to prevent patients with mild-to-moderate disease from worsening and needing hospitalization. It's given as a one-time treatment through an IV and is still going through more testing to establish its safety and effectiveness. Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs.

U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month. There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own.

The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV.  source

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