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全球首个!英国批准首款抗新冠口服药

英国药品与保健品管理局11月4日宣布,已批准美国默克公司研发的口服抗新冠药物莫那比拉韦用于特定新冠患者。这是全球面世的首款抗新冠口服药物。

全球首个!英国批准首款抗新冠口服药 [Photo/Agencies]


The first pill designed to treat symptomatic Covid-19 has been approved by the UK medicines regulator.
英国药品监管机构批准了首款用于治疗症状性新冠肺炎的药物。


The tablet - molnupiravir - will be given twice a day to vulnerable patients recently diagnosed with the disease.
近期确诊新冠肺炎的虚弱患者将每天服用两次莫那比拉韦(molnupiravir)。


In clinical trials the pill, originally developed to treat flu, cut the risk of hospitalization or death by about half.
在临床试验中,该药物将因感染新冠病毒住院或死亡的风险降低了一半左右。该药物原本用于治疗流感。


Health Secretary Sajid Javid said the treatment was a "gamechanger" for the most frail and immunosuppressed.
英国卫生大臣赛义德·贾维德称,这种药物对身体虚弱和免疫功能不全的人来说意义重大。


First oral treatment
首款抗新冠口服药


Molnupiravir, developed by the US drug companies Merck, Sharp and Dohme (MSD) and Ridgeback Biotherapeutics, is the first antiviral medication for Covid-19 which can be taken as a pill rather than injected or given intravenously.
莫那比拉韦由美国制药公司默克和Ridgeback生物治疗公司研发,是第一款抗新冠口服药,而非静脉注射类药物。


The UK has agreed to purchase 480,000 courses with the first deliveries expected in November.
英国政府已批准订购48万个疗程,首批药物预计于11月交付。


Initially it will be given to both vaccinated and unvaccinated patients through a national study, with extra data on its effectiveness collected before any decision to order more.
初期,该药物将通过一项全国性研究提供给接种过疫苗和未接种过疫苗的患者,并在决定订购更多之前收集有关其有效性的更多数据。


The drug needs to be given within five days of symptoms developing to be most effective.
该药物需在出现症状五天内服用才能发挥最大疗效。


The new treatment targets an enzyme that the virus uses to make copies of itself, introducing errors into its genetic code. That should prevent it from multiplying, so keeping virus levels low in the body and reducing the severity of the disease.
莫那比拉韦针对病毒用于自我复制的一种酶,将错误信息引入其遗传基因。这样能阻止病毒繁殖,从而使体内病毒浓度保持较低水平,降低疾病的严重程度。


Merck said that approach should make the treatment equally effective against new variants of the virus as it evolves in the future.
默克公司表示,未来新冠病毒继续变异,这种治疗手段对新的病毒变种同样有效。


The UK regulator, the MHRA, said the tablet had been authorized for use in people who have mild to moderate Covid-19 and at least one risk factor for developing severe illness such as obesity, old age, diabetes or heart disease.
英国药品和保健品管理局表示,莫那比拉韦已获批用于轻度至中度症状的新冠患者,这些患者有至少一个恶化为重症的风险因素,包括肥胖、年龄大、糖尿病和心脏病等。

 

Clinical trials
临床试验


Earlier clinical trials of molnupiravir on 775 patients who had recently caught Covid-19 found:
莫那比拉韦对775名最近感染新冠病毒患者的早期临床试验发现:


7.3% of those given the drug were hospitalized
7.3%的服药者住院治疗

that compares with 14.1% of patients who were given a placebo or dummy pill
相比之下,服用安慰剂或虚拟药片的患者有14.1%住院治疗

there were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of Covid-19
服用莫那比拉韦的一组没有患者死亡,但在试验中服用安慰剂的8名患者死于新冠病毒

 

The results were published in a press release and have not yet been peer-reviewed.
该研究结果发表在新闻稿件中,尚未经过同行评审。


But data suggest molnupiravir needs to be taken soon after symptoms develop to have an effect.
但数据表明,需要在症状出现后立即服用莫努匹拉韦才能起效。


In its approval document, the MHRA recommends the drug is used "as soon as possible" following a positive Covid-19 test and within five days of symptoms onset.
在英国药品和保健品管理局的批准文件中,该机构建议在新冠病毒检测呈阳性后以及症状出现后五天内“尽快”服用该药物。


The UK government has not disclosed how much its initial contract for 480,000 courses of molnupiravir is worth. But US authorities recently made an advance purchase of 1.7 million courses at a cost of roughly $1.2 billion, or $700 for each patient.
英国政府尚未透露其48万个疗程的莫那比拉韦的初始合同价。但美国当局最近预购了170万个疗程,成本约为12亿美元(约合人民币76.8亿元),即每位患者700美元(约合人民币4480元)。


Merck is the first company to report trial results of a pill to treat Covid-19, but other companies are working on similar treatments.
默克公司是第一家公布抗新冠病毒药物试验结果的公司,不过其他公司也在研究类似的药物。


Its US rival Pfizer has started trials of two different antiviral tablets, while Swiss company Roche is working on a similar medication.
其竞争对手美国辉瑞公司已开始试验两种不同的抗病毒片剂,而瑞士罗氏公司正在研制一种相似的药物。

 

来源:英国广播公司
编辑:董静

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