美国FDA批准辉瑞和Merck两款Covid治疗药物,让病人在生病住院前可以在家服用。加拿大批准辉瑞抗病毒新药。

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373

Are we turning the corner on Covid-19 treatments?​

Covid-19 treatments are key to living with the virus. Here’s where we’re at.

By Kelsey Piper Nov 11, 2021, 9:00am EST
Pedestrians walk past a wall billboard that reads “Science wants to cure people more than any disease wants to exist.”
Pedestrians walk past Pfizer’s New York headquarters on November 7, 2021. Pfizer aims to submit data from clinical trials of its experimental Covid-19 pill to US regulators by Thanksgiving, potentially clearing the way for an emergency-use authorization.

Stephanie Keith/Bloomberg via Getty Images

When the vaccines against Covid-19 first started rolling out less than a year ago, there was widespread hope that it signaled the beginning of the end of the pandemic. As we head into another winter, however, things are much more uncertain than many people had hoped: As much as we might want to put the pandemic behind us, the delta surge and vaccine hesitancy have ensured that Covid-19 has lingered.

But there’s another new development on the horizon that, in combination with vaccines, might really be a game changer.

In recent months, researchers have made some advances in figuring out how to treat Covid-19 once you’ve contracted it. Of particular promise are medications available in a form that should be especially useful in the fight against the virus: pills. Pills are easy to store and ship, making them a more feasible option for worldwide distribution, and they don’t tax already overloaded hospital resources during a surge.

To understand why the development of anti-Covid pills is a big deal, think about how we’ve been able to treat Covid-19 thus far. In the nearly two years since this coronavirus started spreading, we’ve learned a lot about how to care for patients who are sick enough to require hospital care. Cheap, widely available drugs such as dexamethasone have substantially reduced the hospital mortality rate for severe Covid-19.

But there are fewer options for sick people who haven’t been hospitalized. The one outpatient treatment authorized for emergency use and widely available in the US is monoclonal antibodies, which work quite well but must be administered as either a single IV infusion or a series of four shots in a medical setting.

Uptake of monoclonal antibodiesreportedly isn’t as high as it should be, and the treatment itself, while free to US patients, is pricey, costing the US government $2,100 per dose.

So as effective as monoclonal antibodies have been, there’s still a large void in our early treatment arsenal. When the virus surges in an area, hospitals get overwhelmed, meaning that people who end upneeding treatment might not get it. Meanwhile, people with mild to moderate cases are told to stay home, where they have very few options.

The lack of good early treatments for Covid-19 has led to high demand for drugs that have gained adherents but probably don’t help all that much, from hydroxychloroquine to metformin to ivermectin. The effort to figure out how and whether those treatments work has been marred by widespread fraud in published research investigating them.

But there’s finally been some real progress on identifying Covid-19 treatments that not only are highly effective but also available for Covid-19 sufferers to take at home.

Fighting Covid-19 with a pill​

One pill that’s been shown to be effective against the disease wasn’t even made to fight Covid-19.

Fluvoxamine is a cheap, generic antidepressant that’s been around since the 1990s. It also appears to reduce hospitalizations and deaths by Covid-19 by up to 30 percent, according to the results of a randomized, controlled trial, the initial findings of which I reported on back in August. Results from the so-called TOGETHER study, which tested fluvoxamine and some other treatments, were recently published in The Lancet medical journal.

How does fluvoxamine work in the case of Covid-19? Researchers’ best guess is that it modulates the body’s inflammatory response and reduces lung damage as the immune system fights off the coronavirus.

A 30 percent reduction in hospitalizations and deaths may not strike you as particularly high, but the drug is cheap (only $4 per dose) and has a demonstrated track record of safety (it’s FDA approved), which should strengthen the case for adding it to the global arsenal in the fight against the pandemic.

Despite encouraging trial results and a great safety profile, the National Institutes of Health’s treatment guidelines for fluvoxamine haven’t been updated since April, and the drug isn’t widely prescribed or recommended for Covid-19 patients. Doctors can make the call to prescribe fluvoxamine as an off-label treatment, but many might be reluctant to do so until the drug’s official guidelines incorporate evidence from large, reputable clinical studies demonstrating its efficacy. Now that the TOGETHER results have been published, though, doctors might be more willing to write those prescriptions.

An even more promising pill is Merck’s molnupiravir. Unlike fluvoxamine, it’s not already FDA approved, but it’s also repurposed after a fashion: Merck began developing the antiviral as an influenza treatment. It’s taken as a batch of up to four pills, twice a day for five days.

In Merck’s studies, molnupiravir reduced Covid-19 hospitalizations and deaths by about half. The UK granted the drug “conditional authorization” last week; the FDA has been reviewing the data since mid-October and will hold a hearing to discuss the data on November 30.

The US government has committed to purchasing 1.7 million courses of the drug for about $700 apieceonce it’s approved or authorized for emergency use. Merck has licensed the generic manufacturing of molnupiravir at a much, much cheaper price in more than 100 developing countries, and the success of that program will be key for molnupiravir to make a difference worldwide.

Finally, Pfizer’s Paxlovid is a little farther away from widespread availability, but recent research suggests it might be poised to make a huge difference. Paxlovid is an antiviral developed to target Covid-19 specifically by blocking a specific enzyme the virus needs to reproduce itself.

An interim analysis of an ongoing trial published by Pfizer last week noted that Paxlovid reduced the risk of hospitalization or death by 89 percent for adults at risk of severe Covid-19. That’s a huge effect size, and it’s always wise to be a little skeptical of results that good.

But if the studies hold up — and there are more ongoing that could support or refute the existing data — that could effectively mean the end of the pandemic. For many people, getting sick from Covid-19 would be much less of a danger.

Down the pike​

There are many other early Covid-19treatments under development and in testing, too. For instance, researchers in the UK found that inhaled budesonide, a medication used to treat asthma, reduced recovery time, hospital admissions, and deaths in Covid-19 patients; studies are underway to confirm those results and to check how budesonide interacts with other early treatments.

The antiviral remdesivir offers little benefit for Covid-19 patients and probably “makes little or no difference” in mortality, according to a systematic review of multiple studies on its effects. Gilead Sciences is developing a pill version for non-hospitalized patients in the hope that remdesivir might work better as an early treatment; some early evidencebears that out.

The FDA database of clinical trials for Covid-19 lists hundreds of studies on potential treatments, from repurposed medications to newly developed medicines to combination protocols of other promising drugs. The vast majority of those won’t pan out, but it only takes a few.

I suspect I’m not alone in being desperate for a return to normal — to concerts and indoor events, to in-person playdates for kids, for frictionless travel — while still being conscious of the fact that more than a thousand people are still dying of Covid-19 in the US every day.

The virus might be approaching endemicity, but those death counts needn’t become a new normal. By developing better at-home therapies, we can beat the disease back among both vaccinated people with breakthrough infections and individuals who have declined to be vaccinated. There’s some really good news here, and we owe a debt to the scientists who’ve worked to develop, test, and understand these drugs.

 

贵圈

Attacks on me, frankly, are attacks on science :)
注册
2014-10-21
消息
19,769
荣誉分数
3,754
声望点数
273
"Fluvoxamine is not FDA approved to treat COVID-19.Oct. 29, 2021"

你这么跪舔官方,怎么能散布谣言呢?
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373
原话在哪里?
"Fluvoxamine is not FDA approved to treat COVID-19.Oct. 29, 2021"

你这么跪舔官方,怎么能散布谣言呢?
 

茶马盐铁

我想看看自定义头衔到底能有多少字。继续加,看系统什么时候把这个字符串截断。呃,居然还有?那就继续吧。
注册
2015-08-14
消息
11,567
荣誉分数
2,914
声望点数
273
抗抑郁? 要啥药嘛! 中国早就有先进经验了。

进学习班, 白天参加义务劳动,晚上学习毛选。
自己种地自己吃。 怕饿肚子, 就多劳动。用劳动改造自己, 用毛(习)选改造自己的思想。
学员互相之间揭发批斗。 每个礼拜写思想汇报, 批评与自我批评相结合。
剥去伪装,洗洗澡, 洗洗脸, 正正冠,互相之间搓搓澡。
。。。

进个一年半载的, 包好,包好!
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373

新冠肺炎:关于新冠口服胶囊 你需要知道的四个问题​

2021年11月11日
Molnupiravir pills

图像来源,MERCK
美国默克药厂称,其实验效果十分好,并将在未来两周内为在美国申请紧急使用授权。

两种Covid-19口服新药2021年秋先后问世,被普遍视为结束新冠疫情努力的重要突破。

美国默克(Merck,又称默沙东、MSD)公司的治疗新冠肺炎口服胶囊莫努匹拉韦(Molnupiravir)11月初在英国获准紧急使用。英国此举世界第一,默克新药则在新冠口服药研发竞赛中拔得头筹。默克称临床试验结果表明此药可使感染者住院或死亡风险降低约一半。

美国辉瑞(Pfizer)公司随即发布新闻,新冠口服胶囊 Paxlovid 亮相。辉瑞称此药2/3期临床试验千余人参加,结果显示可令住院或死亡风险降低85% - 89%。此药的使用授权申请已向美国食品与药物署(FDA)递交。

两种口服药物的相关数据都尚未在经同行审评的专业期刊发表。

全球已有多种疫苗可用于预防感染,但针对新冠病毒感染者的治疗选择有限。目前不必住院但病情恶化风险较高的患者可以使用抗病毒药物治疗,但必须在医院或诊所接受静脉注射。

抗病毒药瑞德西韦2020年10月获准用于新冠治疗,但需要静脉注射,一次给药需要30分钟到120分钟不等,每天注射一次,根据所需剂量不同,疗程持续5天到10天。

相比之下,在家服用处方口服药五天取得类似疗效,自有其优势。

病毒

图像来源,GETTY IMAGES
Banner

效果如何?​

从两家公司提供的试验数据来看,辉瑞的Paxlovid胶囊更有效,但目前两家提供的数据都不完整。

辉瑞的临床试验结果显示,在出现症状后三天内服药,患者住院或死亡风险降低 89%;五天内给药风险降低 85%。

默克公司称它的口服药在出现症状后五天内服用,患者住院或死亡风险可降低约50%。发病后三天内服药的数据没有提供。

默克新冠口服胶囊在英国的品牌名称是 Lavgevrio,已获得监管部门的批准用于轻度至中度Covid-19患者和有重症风险的人;重症风险因素包括肥胖、老年、糖尿病或心脏病。

辉瑞新药使用授权待批准。
Covid patient in hospital

图像来源,HANDOUT
Molnupiravir在英国获紧急使用授权

如何起作用?​

英国医药监管当局说,根据药物试验结果,在感染早期阶段服用口服药最有效;建议在 COVID-19 检测呈阳性后尽快服药,或在出现症状后五天内使用。

两种药的一个疗程都是五天,即连续五天一日二次服药,辉瑞的药是早上服三粒,晚上三粒,默克的药早上服四粒,晚上四粒。

默克与生物制药公司 Ridgeback Biotherapeutics 合作开发的莫努匹拉韦是一种核苷类似物。爱丁堡纳皮尔大学学者解释说,其药理机制是干扰病毒的遗传密码使之出错,当病毒繁殖时,进入病毒RNA的药物会导致突变不断累积,每次复制都会增加,最终导致“错误灾难”,即过度突变致使病毒无法完全复制,然后自行消失。

此药针对病毒产生随机突变,因此新冠病毒很难产生耐药性。

莫努匹拉韦与流感药达菲( Tamiflu)有若干相似之处,包括功能、易用性和可用性等,但两者有一个本质区别:药理机制 —— 达菲通过干扰流感病毒进入细胞发挥作用,而不是针对病毒RNA的复制。

辉瑞 Paxlovid 属于蛋白酶抑制剂类,通过阻断冠状病毒繁殖所需的酶起作用。由于此药只针对病毒复制所必需的那一部分,因此病原体不会对治疗产生抗药性。

Paxlovid需要与另一种较成熟、使用时间较长的抗病毒药利托纳韦(ritonavir)一起使用;利托纳韦可以提高蛋白酶抑制剂的活性,主要副作用是会引起胃肠道不适,还可能会干扰其他药物。
pills

图像来源,GETTY IMAGES

安全性如何?​

辉瑞和默克公布的数据都很有限,但两家公司对新冠口服胶囊的安全性都“充满信心”。

辉瑞表示,大约 20% 服药或使用安慰剂的患者出现不良反应,大部分较轻微;1.7% 的服药患者和 6.6% 的使用安慰剂患者出现严重副作用。

默克表示,12%的服用新药的患者和11%的使用安慰剂的患者出现与药物相关的不良反应。

与默克新冠胶囊同类的其他药物在动物试验中发现与先天缺陷有关。但是,默克表示,对新冠口服胶囊的动物试验——比临床试验时间更长、剂量更高——表明它不会导致出生缺陷或癌症。

不过,耶鲁医学院传染病专家阿尔伯特·肖(Albert Shaw)指出,美国食品与药物署(FDA) 显然需要在审批过程中核查评估这方面安全性的数据。

由于莫努匹拉韦通过破坏冠状病毒复制 RNA 的方式起作用,因此令人担心可能会对人类 DNA 或 RNA 产生类似影响。耶鲁医学院传染病专家杰米迈耶说,主要令人担忧的是这种药物可能会干扰胎儿发育所需的 RNA 复制并导致出生缺陷。

默克在其临床试验中没有在孕妇身上测试该药物,排除了怀孕、哺乳或准备怀孕的女性。随着这种药物从临床试验进入市场,这一点很重要。
孕妇、备孕或哺乳期女性不在英国当局批准使用莫努匹拉韦的目标群体之内。
实验室

图像来源,MSD

是否适用于变异毒株?​

是的。

耶鲁医学院 传染病专家阿尔伯特·肖(Albert Shaw)表示,在美国和其他国家/地区进行的研究表明,此药物能够有效对抗包括Delta、Gamma、和 Mu 在内的需加关注的变异毒株。

莫努匹拉韦的药理机制是干扰病毒的遗传密码使之出错,应该对治疗所有变异毒株引起的新冠肺炎都同样有效。

目前这方面数据仍然较少。

辉瑞和默克都表示正在努力扩大新药的全球供应水平。

辉瑞预计到2021年年底将生产 18万个疗程所需药物,2022 年计划生产至少 5千万个疗程的药物。默克预计到2021年年底将生产 1千万个疗程所需药物,2022 年计划至少生产 2千万个疗程的药物。

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373

美国政府与辉瑞达成协议 购买1千万疗程新冠口服药​

2021年11月19日 03:43
  • 美国之音

辉瑞公司提供的图片显示该公司研制的COVID-19口服药。(2021年11月10日)

辉瑞公司提供的图片显示该公司研制的COVID-19口服药。(2021年11月10日)

美国总统拜登星期四(11月18日)宣布,美国已同意从今年晚些时候开始直到2022年购买1千万疗程的辉瑞(Pfizer)新冠病毒口服药。这种新药目前尚未得到批准。

白宫网站发表的声明说,拜登总统说,美国政府正在采取步骤,以确保一旦食品药品管理局(FDA)和疾病控制与预防中心(CDC)批准新药,人们将容易并免费得到这样的治疗方法。

辉瑞公司星期四在其网站上说,如果这种以Plaxlovid商标销售的口服药获得批准,美国政府将为其支付大约52.9亿美元。

本月早些时候,辉瑞在宣布这种新药时说,最新的临床试验显示,该药将与新冠病毒有关的住院和死亡风险减少了89%。

辉瑞是第二家研发出口服新冠药的美国制药商。默克(Merck)今年10月推出了该公司的新冠口服药。默克口服药的临床试验显示,该药把新冠病毒造成的住院和死亡风险减少了50%。

美国食品药品管理局定于本月晚些时候就默克口服药做出决定。英国的药物监管部门已经批准了这一新药。

白宫上个月宣布,美国已经做出了购买170万剂默克口服药的安排,而且如果有必要,还可以增加购买。

拜登在他的声明中说,这些治疗方式有可能被证明是让美国加速摆脱大流行病的另一个关键工具。不过他强调说,疫苗仍然是最有力的工具,并敦促所有仍未接种的人去接种疫苗。

(本文参考了美联社、路透社和法新社的报道。)

 
最后编辑:

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373

新闻:真正的抗新冠特效药来了!​


来源: fuz 于 2021-11-20 06:47:33

真正的抗新冠特效药来了!疫情结束还远吗?
…………
11月4日,美国药企默克宣布其小分子药物Molnupiravir(中文译名“莫努匹韦”)获得英国药监局批准上市,成为全球第一款获批用于治疗成人轻度至中度新冠感染的口服药物

仅一天之后,美国辉瑞制药披露其研发的新冠口服药Paxlovid临床试验结果,在出现症状早期服用,该药可降低新冠患者89%的住院或者死亡风险
…………
医生们的“工具箱”里将有两款专为新冠研发的药物:橙色的Molnupiravir,以及红黑色、印着“COVID-19”字样的Paxlovid,二者均为胶囊在适应症和疗程上很相似。
……………

莫努匹韦将患者的住院风险或死亡风险降低 50%。在随机分组后的第29 天,接受莫努匹韦治疗患者的住院死亡比例为7.3% (28/385),而安慰剂组这一比例为 14.1% (53/377)。在跟踪的28天内,莫努匹韦治疗组没有死亡报告,相比之下,安慰剂组报告了8例死亡。

“Molnupiravir这个名字是以‘雷神之锤’Mjollnir来命名的。这款药物是一种对抗新冠病毒的锤子,不管新冠病毒会进化出什么样的变种。”默克公司全球研发主管这样介绍。这款化合物是一种核苷类似物,它的作用机理是与病毒的RNA聚合酶结合,在合成的RNA分子中引入错误的核苷酸,导致病毒因为RNA中出现过多错误而死亡。

基于独立数据监测委员会的建议和与FDA的沟通结果,默克提前终止该项Ⅲ期研究,并计划尽快向FDA提交紧急使用授权(EUA)申请,同时也将尽快向全球其他国家的监管机构提交上市申请。英国已成为第一个批准该药上市的国家,面对的人群是60岁以上老人或至少有一个引发新冠重症的高危人群,比如肥胖或心脏病。

就在莫努匹韦在英国批准上市的第二天,辉瑞传出另一个抗新冠口服药的好消息,更加令人惊喜。其公布的Paxlovid的II/III期临床中期试验结果,出现症状3天内就服药的高危成年新冠感染者,该药物可以将其住院或病死的风险降低89%“这绝对是针对新冠的一个非常好的药物,是真正的特效药。”王浩然说。
具体来说,出现症状3天内口服Paxlovid药物的患者中,28天观察期内,0.8%(3/389)住院,无死亡;安慰剂组为7.0%(27/385)住院或死亡,其中7例死亡。在出现症状5天内口服Paxlovid的患者中,1%(6/607)住院,无死亡;安慰剂组为6.7%(41/612)住院或死亡,其中10例死亡。

该临床试验原计划招募3000名患者,但同样由于中期的积极结果,在和FDA沟通后停止招募及进一步试验。目前,辉瑞正在向FDA申请紧急使用授权。与此同时,美国政府已经预购了辉瑞新药100多万剂,英国和澳大利亚表示已经和辉瑞达成供应协议,分别是50万剂与10万剂。

辉瑞的Paxlovid是一个组合药:小分子PF-07321332(以下简称“332”)与抗HIV药物利托那韦,后者的目的是减缓 “332”在体内的代谢或分解,以使其在体内保持较高的浓度来对抗病毒。治疗过程为,一次吃两片“332”加一片利托那韦,每天吃两次,连续五天。

与莫努匹韦相比,Paxlovid可以被称为第一款真正意义上针对新冠的特效药,因为前者更像是一款广谱的病毒RNA转录酶抑制剂,而PF-07321332则是专门为新冠研发的,它的作用机理是阻断新冠病毒复制所需的主要蛋白酶“3CL”的活性。

虽然没有在同一个临床试验中进行头对头比较,但临床结果很难不给人留下一个印象:辉瑞的Paxlovid看起来更有效,效果已达到或超过中和抗体王浩然说,莫努匹韦药效虽然相对要差一点,但是它具有更便宜、易合成、抗病毒更广谱、不易产生耐药性等优点。
…………
美国将于11月30日举行会议,审查莫努匹韦的安全性和有效性数据,并投票决定是否授权其上市,一旦获批,美国政府已经以大约12亿美元的价格预先购买了170万个疗程的莫努匹韦,相当于每个疗程大约700美元。此外,与默克达成购买该药物协议的国家至少包括澳大利亚、新加坡和韩国。
………………

针对急性呼吸道病毒感染,抗病毒药物越早服用效果越好,当病毒大量复制的时候,就不好被抑制了。这就需要尽早筛查出感染者,但是对新冠来说,通常确诊的时候已经比较晚了,很难把握服药的最佳窗口期。如果一个人是无症状感染者,就更难以及时被辨别出来


英文报道
健康养生: 要有药了, 白宫买单 - 由fuz发表 - 文学城

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373

FDA authorizes first pill to treat Covid-19​

By Jamie Gumbrecht and Amanda Sealy, CNN

Updated 1:27 PM ET, Wed December 22, 2021

(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.

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373
2 hr 45 min ago

US FDA authorizes second pill to treat Covid-19​

From CNN’s Amanda Sealy and Ben Tinker

The US Food and Drug Administration has now authorized two new antiviral pills to treat Covid-19.

The FDA on Thursday authorized Merck’s antiviral pill, molnupiravir, to treat Covid-19 “for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
This is the second Covid-19 antiviral pill authorized for ill people to take at home, before they get sick enough to be hospitalized. Merck has an agreement with the US government for the company to supply 3.1 million courses of molnupiravir upon this authorization.

Molnupiravir was narrowly recommended by the 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 about 50%.

Dr. Eliav Barr, senior vice president of global medical affairs at Merck, told CNN this month that he was optimistic this treatment would work against the Omicron variant.

“The Omicron variant is primarily different from the other types of Covid at the spike protein. Our drug works in completely different part of the virus. So we’re very optimistic that the drug will continue to be effective against Omicron, and we’re studying that right now," he said.

The FDA authorized Pfizer’s antiviral pill, Paxlovid, on Wednesday.

Remdesivir, sold under the brand name Veklury, is the only antiviral approved by the FDA for treatment of Covid-19. It's given intravenously, not as a pill that can be taken at home.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373
29 min ago

UK approves Pfizer's Covid-19 antiviral pill for high-risk adults​

From CNN's Amy Cassidy

Paxlovid from Pfizer.
Paxlovid from Pfizer. (Frank Hoermann/Sven Simon/dpa/AP)

UK regulators have approved Paxlovid, the antiviral pill developed by Pfizer which, studies suggest, can sharply reduce the risk of hospitalization and death for high-risk adults with Covid-19.

The pill is “safe and effective,” according to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in a statement published online Friday. It is taken in combination with an older antiviral, ritonavir, which slows the drug’s breakdown.

Clinical trials among high-risk adults concluded that one course of Paxlovid, taken twice a day for five days, reduced the risk of Covid-19 related hospitalization and death within 28 days by 89%, compared to a placebo group when taken within three days of the start of symptoms.

The UK has authorized it for people aged 18 and above who have mild to moderate Covid-19 symptoms, and at least one risk factor for developing severe illness, according to the statement.

“The booster campaign, testing and antiviral defences ensure our country is in the strongest possible position to deal with the threat posed by Omicron as we head into the new year,” UK Health Secretary Sajid Javid said in the statement.

The news release added, “It is too early to know whether the omicron variant has any impact on Paxlovid’s effectiveness but the MHRA is proactively working with the company to establish this.”
The US Food and Drug Administration authorized the pill last week.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,459
荣誉分数
6,624
声望点数
373
11 min ago

Canadian officials call Pfizer antiviral drug approval "a new tool" in the toolbox​

From CNN’s Taylor Romine

Pfizer's Paxlovid pill, a COVID-19 antiviral drug.
Pfizer's Paxlovid pill, a COVID-19 antiviral drug. Pfizer/AP

Pfizer's Covid-19 antiviral drug Paxlovid was approved for use by Canada's health agency on Monday, officials announced during a press conference, and said the drug will be a "new tool" in the toolbox of treatment options.

Health officials recommend that the drug, which is five-day treatment that can be taken at home, be prioritized for residents in high-risk groups with mild to moderate Covid-19 symptoms. But ultimately, provinces will make their own guidelines for distribution, they said.

"The authorization today provides a new tool in the toolkit against Covid-19 at a crucial time in the pandemic as we are faced with new variants," said Supriya Sharma, chief medical adviser to the deputy minister. "Importantly, it is a more accessible anti-viral treatment for those at high risk of progression into severe Covid-19."

Health officials said that this will include those who are moderately or severely immunocompromised and people 80 years-old and older who do not have up-to-date vaccinations, said Dr. Theresa Tam, chief public health officer of Canada. In addition, she said people who are age 60 and older who live in rural or underserved areas or are part of the First Nations are recommended for priority access.

It will be required that anyone taking the drug have a positive Covid-19 test, either a PCR or a rapid test, and start treatment within five days of symptoms, health officials said.

Tam said the tests will be distributed on a per-capita basis. Canada ordered an initial quantity of one million treatment doses in December, she said, but officials are still working to firm up an official delivery schedule. Regardless, the antiviral pill will be in short supply when it is first distributed as the drug is in high demand around the world, Tam said.

Several reporters asked about concerns of long wait times for Covid-19 test results and how that might interfere with getting timely treatment, but several health officials said that they hope that those in high-risk categories are prioritized for test results and will allow quick treatment.

"That has to be worked out on the ground, but it is challenging, there is no doubt about it," Tam said. "So I do think increasing awareness to the at-risk populations that there may be treatments available now, even though we anticipate that at the beginning the supply will not be great anywhere."

Tam added that each community is going to be "a little different" in how they roll out the drug and that it is best to pay attention local guidelines.

Health officials said that ultimately, they hope that the anti-viral will help blunt the severity of the illness and will help keep more people out of the hospital to reduce the strain on the health care system.
 
顶部