全球首個!英國批準(zhǔn)首款抗新冠口服藥 First pill to treat Covid gets approval in UK
中國日報網(wǎng) 2021-11-05 16:25
英國藥品與保健品管理局11月4日宣布,已批準(zhǔn)美國默克公司研發(fā)的口服抗新冠藥物莫那比拉韋用于特定新冠患者。這是全球面世的首款抗新冠口服藥物。
The first pill designed to treat symptomatic Covid-19 has been approved by the UK medicines regulator.
英國藥品監(jiān)管機構(gòu)批準(zhǔn)了首款用于治療癥狀性新冠肺炎的藥物。
The tablet - molnupiravir - will be given twice a day to vulnerable patients recently diagnosed with the disease.
近期確診新冠肺炎的虛弱患者將每天服用兩次莫那比拉韋(molnupiravir)。
In clinical trials the pill, originally developed to treat flu, cut the risk of hospitalization or death by about half.
在臨床試驗中,該藥物將因感染新冠病毒住院或死亡的風(fēng)險降低了一半左右。該藥物原本用于治療流感。
Health Secretary Sajid Javid said the treatment was a "gamechanger" for the most frail and immunosuppressed.
英國衛(wèi)生大臣賽義德·賈維德稱,這種藥物對身體虛弱和免疫功能不全的人來說意義重大。
First oral treatment
首款抗新冠口服藥
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.
莫那比拉韋由美國制藥公司默克和Ridgeback生物治療公司研發(fā),是第一款抗新冠口服藥,而非靜脈注射類藥物。
The UK has agreed to purchase 480,000 courses with the first deliveries expected in November.
英國政府已批準(zhǔn)訂購48萬個療程,首批藥物預(yù)計于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,該藥物將通過一項全國性研究提供給接種過疫苗和未接種過疫苗的患者,并在決定訂購更多之前收集有關(guān)其有效性的更多數(shù)據(jù)。
The drug needs to be given within five days of symptoms developing to be most effective.
該藥物需在出現(xiàn)癥狀五天內(nèi)服用才能發(fā)揮最大療效。
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.
莫那比拉韋針對病毒用于自我復(fù)制的一種酶,將錯誤信息引入其遺傳基因。這樣能阻止病毒繁殖,從而使體內(nèi)病毒濃度保持較低水平,降低疾病的嚴(yán)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,未來新冠病毒繼續(xù)變異,這種治療手段對新的病毒變種同樣有效。
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.
英國藥品和保健品管理局表示,莫那比拉韋已獲批用于輕度至中度癥狀的新冠患者,這些患者有至少一個惡化為重癥的風(fēng)險因素,包括肥胖、年齡大、糖尿病和心臟病等。
Clinical trials
臨床試驗
Earlier clinical trials of molnupiravir on 775 patients who had recently caught Covid-19 found:
莫那比拉韋對775名最近感染新冠病毒患者的早期臨床試驗發(fā)現(xiàn):
7.3% of those given the drug were hospitalized
7.3%的服藥者住院治療
that compares with 14.1% of patients who were given a placebo or dummy pill
相比之下,服用安慰劑或虛擬藥片的患者有14.1%住院治療
there were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of Covid-19
服用莫那比拉韋的一組沒有患者死亡,但在試驗中服用安慰劑的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.
該研究結(jié)果發(fā)表在新聞稿件中,尚未經(jīng)過同行評審。
But data suggest molnupiravir needs to be taken soon after symptoms develop to have an effect.
但數(shù)據(jù)表明,需要在癥狀出現(xiàn)后立即服用莫努匹拉韋才能起效。
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.
在英國藥品和保健品管理局的批準(zhǔn)文件中,該機構(gòu)建議在新冠病毒檢測呈陽性后以及癥狀出現(xiàn)后五天內(nèi)“盡快”服用該藥物。
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.
英國政府尚未透露其48萬個療程的莫那比拉韋的初始合同價。但美國當(dāng)局最近預(yù)購了170萬個療程,成本約為12億美元(約合人民幣76.8億元),即每位患者700美元(約合人民幣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藥物試驗結(jié)果的公司,不過其他公司也在研究類似的藥物。
Its US rival Pfizer has started trials of two different antiviral tablets, while Swiss company Roche is working on a similar medication.
其競爭對手美國輝瑞公司已開始試驗兩種不同的抗病毒片劑,而瑞士羅氏公司正在研制一種相似的藥物。
來源:英國廣播公司
編輯:董靜