(CNN) 美国食品和药物管理局周三授权辉瑞的抗病毒药 Paxlovid 治疗 Covid-19。
这是首个获准让病人在生病住院之前可以在家服用的抗病毒 Covid-19 药丸。
体重至少 88 磅且 SARS-CoV-2 检测呈阳性的 12 岁及以上的高危人群有资格接受这种治疗，并且需要由医生开处方。
根据 FDA 的一份声明，该药丸“应在确诊 Covid-19 后并在出现症状的五天内尽快开始使用”。
Paxlovid 结合了一种名为 nirmatrelvir 的新抗病毒药物和一种名为 ritonavir 的较老的抗病毒药物，每天服用两次，每次服用三片，持续五天。
上周，辉瑞（Pfizer）发布了最新结果，显示如果在出现首次出现症状的几天内给予高危成人，这种治疗可将住院或死亡的风险降低 89%。如果在出现症状的前五天内给药，疗效相似：88%。
“今天对 PAXLOVID 的授权代表了科学将如何帮助我们最终战胜这种流行病的另一个巨大例子，这种流行病即使在两年后仍继续扰乱和破坏世界各地的生活。这种突破性疗法已被证明可以显着减少住院治疗和死亡并且可以在家中接受，将改变我们治疗 COVID-19 的方式，并有望帮助减轻我们的医疗保健和医院系统面临的一些重大压力，”辉瑞董事长兼首席执行官 Albert Bourla 在一份声明中说。 “辉瑞随时准备在美国开始交付，以帮助尽快将 PAXLOVID 送到合适的患者手中。”
11 月，拜登政府宣布将斥资 52.95 亿美元购买 1000 万个疗程。拜登总统表示，他对辉瑞的“有希望的数据”感到鼓舞，并表示该药物将“标志着我们在摆脱大流行的道路上向前迈出了重要的一步”。
他称 Paxlovid 是“我们对抗病毒的潜在强大工具，包括 Omicron 变体”，但强调接种疫苗和接受加强注射仍然是“我们拯救生命的最重要工具”。
FDA 在一份声明中强调，Paxlovid 不适用于 Covid-19 的暴露前或暴露后预防，并且“不能替代建议接种 COVID-19 疫苗和加强剂量的个人的疫苗接种。”
另外，默克公司已为其抗病毒药丸莫诺匹韦申请紧急使用授权。 11 月底，FDA 顾问以 13 票对 10 票的投票结果勉强推荐了它，因为数据显示它可以将高危成人的住院或死亡风险降低 30%。这低于之前的分析，表明该数字可能约为 50%。 FDA 尚未宣布是否会批准这种治疗。
Remdesivir 以 Veklury 品牌销售，是 FDA 批准用于治疗 Covid-19 的唯一抗病毒药物。它是静脉注射的，而不是可以在家服用的药丸。
FDA authorizes first pill to treat Covid-19
(CNN)The US Food and Drug Administration on Wednesday authorized Pfizer's antiviral pill, Paxlovid, to treat Covid-19.
This is the first antiviral Covid-19 pill authorized for ill people to take at home, before they get sick enough to be hospitalized.
High-risk individuals age 12 and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test are eligible for this treatment and will need to have it prescribed by a doctor.
The pill "should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset," according to an FDA statement.
Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir and is administered as three pills given twice a day for five days.
Last week, Pfizer released updated results that showed the treatment cut the risk of hospitalization or death by 89% if given to high-risk adults within a few days of their first symptoms. If given within the first five days of symptoms, the efficacy was similar: 88%.
"Today's authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems," Pfizer Chairman and CEO Albert Bourla said in a statement. "Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible."
In November, the Biden administration announced that it would purchase 10 million treatment courses for $5.295 billion. President Biden said he was encouraged by the "promising data" from Pfizer and said the drug would "mark a significant step forward in our path out of the pandemic."
He called Paxlovid a "potentially powerful tool in our fight against the virus, including the Omicron variant," but stressed that getting vaccinated and receiving a booster shot remained "the most important tools we have to save lives."
The FDA emphasized in a statement that Paxlovid is not for pre- or post-exposure prevention of Covid-19 and "is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended."
Separately, Merck has requested emergency use authorization for its antiviral pill, molnupiravir. It was narrowly recommended by FDA's advisers in a 13-10 vote at the end of November after data showed it cut the risk of hospitalization or death by 30% among high-risk adults. This was lower than an earlier analysis suggesting that number could be around 50%. The FDA has not announced whether it will authorize the treatment.
Remdesivir, sold under the brand name Veklury, is the only antiviral approved by FDA for treatment of Covid-19. It's given intravenously, not as a pill that can be taken at home.
