美国药监局批准首款新冠口服治疗药物

美国食品和药物管理局日前授予辉瑞的新冠口服治疗药物紧急使用授权。这款名为Paxlovid的口服药可供患者在家服用。

美国食品和药物管理局日前授予辉瑞的新冠口服治疗药物紧急使用授权。据悉，这款名为Paxlovid的口服药是美国药监局授权的第一款专门用于对抗新冠病毒的口服抗病毒药物。

In a highly anticipated decision, the Food and Drug Administration authorized the first antiviral pill to treat COVID-19 at home.

在万众期待下，美国食品药品监督管理局日前批准了首款家庭用治疗新冠肺炎的口服抗病毒药物。

The pill, called Paxlovid, is made by Pfizer. It's taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral.

这款名为Paxlovid的口服药是辉瑞公司生产的。该药须和抗病毒药物利托那韦一起服用，每日两次，一个疗程要连续服用五天。

"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

美国药监局药物评估和研究中心主任派翠西亚·卡瓦佐尼博士表示：“首款新冠口服治疗药物今日获批，标志着我们迈出了抗击全球疫情的一大步，在出现新变异株的疫情关键时刻提供了抗击新冠的新工具，并承诺让新冠重症高风险人群更便于获得抗病毒治疗。”