BBC:美國完全批准了雷姆昔韋作為新冠病毒用藥:
醫院的患者將可用這種藥物,但聯合國衛生機構表示它的效果不大。
US gives full approval for remdesivir Covid drug
The drug will be given to patients in hospitals, but the UN health agency says it has little effect.
美國監管機構已完全批准抗病毒藥物瑞姆昔韋可在醫院治療Covid-19患者。
美國食品和藥物管理局(FDA)表示,該藥物的品牌Veklury在臨床試驗期間平均將恢復時間縮短了五天。FDA在一份聲明中說:“ Veklury是首個獲得FDA批准的COVID-19治療藥物。”
世界衛生組織(WHO)上週表示,雷姆昔韋對患者的生存幾乎沒有影響。世衛組織表示,這是基於自己的研究-但該藥物的製造商吉利德(Gilead)拒絕了該試驗的結果。
自5月份以來,雷姆昔韋僅在美國被授權用於緊急用途。在唐納德·特朗普總統對Covid-19測試呈陽性後,最近才將其發送給他。 此後他已康復。
US regulators have given full approval for the antiviral drug remdesivir to treat Covid-19 patients in hospitals.
The US Food and Drug Administration (FDA) said Veklury, the drug's brand name, cut the recovery time on average by five days during clinical trials.
"Veklury is the first treatment for COVID-19 to receive FDA approval," the FDA said in a statement.
The WHO said this was based on its own study - but the drug's manufacturer Gilead rejected the findings of the trial.
Remdesivir had been authorised for emergency use only in the US since May.
It was recently given to President Donald Trump after he tested positive for Covid-19. He has since recovered.
What did the FDA say?
In the statement, the FDA said the drug was approved on Thursday "for use in adult and paediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of Covid-19 requiring hospitalisation".
"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic," said FDA Commissioner Stephen Hahn.
The regulator said its decision was supported by the analysis of data from "three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe Covid-19".
One of the studies showed that that "the median time to recovery from Covid-19 was 10 days for the Veklury group compared to 15 days for the placebo group".
What about the WHO study?
For its Solidarity clinical trial, the WHO tested the effects four potential treatments - remdesivir was one, but they also looked at malaria drug hydroxychloroquine, auto-immune drug interferon, and the HIV drug combination of lopinavir and ritonavir.
Dexamethasone, a low-cost steroid now widely used on Covid patients in intensive care in the UK, was not included in this study.
The four drugs were tested with 11,266 adult patients in total, across 500 hospitals in more than 30 different countries.
The results, which are yet to be peer-reviewed, suggested that none of these treatments had a substantial effect on mortality or on the length of time spent in hospital, the WHO said.