FDA authorizes 1st antiviral pill for COVID
美國藥監(jiān)局批準(zhǔn)首款新冠口服治療藥物
In a highly anticipated decision, the Food and Drug Administration authorized the first antiviral pill to treat COVID-19 at home.
在萬眾期待下,美國食品藥品監(jiān)督管理局日前批準(zhǔn)了首款家庭用治療新冠肺炎的口服抗病毒藥物。
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.
這款名為Paxlovid的口服藥是輝瑞公司生產(chǎn)的。該藥須和抗病毒藥物利托那韋一起服用,每日兩次,一個療程要連續(xù)服用五天。
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"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."
美國藥監(jiān)局藥物評估和研究中心主任派翠西亞·卡瓦佐尼博士表示:“首款新冠口服治療藥物今日獲批,標(biāo)志著我們邁出了抗擊全球疫情的一大步,在出現(xiàn)新變異株的疫情關(guān)鍵時刻提供了抗擊新冠的新工具,并承諾讓新冠重癥高風(fēng)險人群更便于獲得抗病毒治療!
The Pfizer treatment could help keep people infected with the coronavirus from getting so sick that they need to be hospitalized.
這款輝瑞口服藥能有助于防止新冠病毒感染者發(fā)展成重癥,避免住院治療。
The results from a Pfizer study involving more than 2,200 people at high risk for developing serious COVID-19 found Paxlovid reduced the risk of hospitalization or death by 89%, compared with a placebo, when taken within three days of first symptoms of illness. When taken within five days, the drug reduced the risk of hospitalization and death by 88%.
一項(xiàng)涵蓋了2200多名新冠重癥高風(fēng)險患者的輝瑞研究結(jié)果發(fā)現(xiàn),相比安慰劑,患者在出現(xiàn)早期新冠癥狀三日內(nèi)服用Paxlovid能將住院或死亡風(fēng)險降低89%,在五日內(nèi)服用能降低88%。
Early results from another Paxlovid study showed a 70% reduction in hospitalization risk among several hundred people at lower risk for severe disease.
另一項(xiàng)對Paxlovid口服藥的研究涵蓋了數(shù)百名新冠重癥低風(fēng)險患者,早期結(jié)果顯示,可以將這一人群的住院風(fēng)險降低70%。
Although it's not certain, Paxlovid's efficacy is unlikely to be reduced in treating people infected with the omicron variant of the coronavirus virus. The drug, which belongs to a family called protease inhibitors, doesn't target the virus's spike protein, as the vaccines do.
盡管尚不確定,但是用Paxlovid來治療奧密克戎變異株感染者應(yīng)該也同樣有效。與疫苗作用的靶標(biāo)不一樣,Paxlovid是一種蛋白酶抑制劑,針對的不是病毒的纖突蛋白。
The federal government has a contract with Pfizer to buy 10 million courses of the treatment for $5.3 billion. But initial supplies of Paxlovid will be limited. The company says it will have 180,000 courses of treatment ready by the end of the year.
美國聯(lián)邦政府已和輝瑞公司簽約,以53億美元(約合人民幣338億元)的價格購入1000萬個療程的藥物。但是Paxlovid的初期供應(yīng)量會比較有限。輝瑞表示,年底前將生產(chǎn)出18萬個療程的藥物。
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