Updated 0940 GMT (1740 HKT) July 27, 2022
A version of this story appeared in CNN's Meanwhile in China newsletter, a three-times-a-week update exploring what you need to know about the country's rise and how it impacts the world. Sign up here.
Updated 0940 GMT (1740 HKT) July 27, 2022
A version of this story appeared in CNN's Meanwhile in China newsletter, a three-times-a-week update exploring what you need to know about the country's rise and how it impacts the world. Sign up here.
CNN's Beijing bureau contributed to this report.
US: FDA approves coronavirus drug remdesivir despite doubts about effectiveness
Though remdesivir can reduce the mortality rate and the duration of the illness COVID-19, it's not considered entirely effective. Nevertheless, US authorities have now approved the drug for use against the disease.23 October 2020
The US Food and Drug Administration (FDA) has approved the drug remdesivir for the treatment of COVID-19, issuing a statement on Friday, October 23. The drug had previously been approved in the US only under an Emergency Use Approval (EUA). In Europe, the product had also received an EUA in July for the treatment of certain COVID-19 patients.
Remdesivir came into focus as a potential cure immediately after the first infections of the novel coronavirus were reported in China. Remdesivir was originally developed to treat Ebola infections, but it also showed effectiveness against SARS and MERS coronaviruses in laboratory tests. The new SARS-CoV-2 is considered a variant of the 2002 SARS pathogen.
The drug was developed by the US pharmaceutical company Gilead Sciences as GS-5734. At the outset of the pandemic, it was not approved by any country.
It has since been used in the context of emergency use, as well as in the context of scientific studies in numerous countries. Gilead Sciences gave the drug the brand name Veklury in Autumn 2020.
After an initial clinical trial in the US showed positive results in May 2020, the FDA granted the EUA. Since then, remdesivir was able to be used in hospitals for the treatment of individual patients with the lung disease COVID-19 outside clinical trials.
Read more: Is compulsory licensing of remdesivir a feasible option?
The World Health Organization (WHO) published a non-peer-reviewed preprint study on MedRxiv on October 15 showing that remdesivir barely reduces the mortality rate of COVID-19 patients. The study is a result of the so-called 'SOLIDARITY Trial' in which the data of 11,266 patients was evaluated.
Gilead Sciences in a statement argued that by having the study published as a preprint, "the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion."
In the same statement, the companyreferenced another study with 1062 volunteers, that was recently published in the New England Journal of Medicine (NEJM), which showed that remdesivir could reduce the average healing time from 15 to 10 days.
Gilead Sciences filed an application for regular approval of the drug with the FDA on August 7, 2020.
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The antiviral effect of remdesivir derives from its function as a so-called nucleotide analogue. The active substance inhibits the RNA polymerase (RdRp) of viruses such as Ebola and MERS because its structure is similar to RNA building blocks. During virus replication, these are erroneously incorporated into the genetic strands of the new virus copies. Truly functional new viruses cannot be created in this way.
Although remdesivir did not prove to be really effective in fighting Ebola, cell culture experiments and initial experiments on macaques showed that it had a promising effect against the coronaviruses SARS and MERS-CoV, which are closely related to SARS-CoV-2.
Early clinical trials with remdesivir carried out in the US and China were intended to show if the drug also helps against COVID-19.
Read more: Coronavirus: EU approves COVID-19 drug remdesivir
Initial positive results of an early randomized clinical trial in the US were announced on April 29, 2020 directly from the White House in Washington. Speaking about remdesivir at a press conference with US President Donald Trump at the White House, the director of the National Institute for Allergy and Infectious Diseases (NIAID), Anthony Fauci, then stated: "This will be the standard of care."
A total of 1,063 patients with varying degrees of severity of the disease had taken part in the NIAID-funded study, the 'Adaptive COVID-19 Treatment Trial', and were treated with remdesivir or a placebo for 10 days.
In such a randomized double-blind study, neither the treating physicians nor the patients know who is injected daily with the active substance and who receives a placebo. This is to prevent any expectations of the drug from possibly distorting the actual results.
Read more: Coronavirus crisis: Children suffer most from being locked down
The results were similar, albeit not quite as clear as those from the new NEJM study. According to NIAID, preliminary results suggested that COVID-19 patients receiving remdesivir had, on average, a 31% faster recovery time than patients given the placebo. Patients that received remdesivir had an average recovery time of 11 days and patients receiving the placebo had an average recovery time of 15 days.
The mortality rate in the remdesivir-treated group was 8% compared to 11.6% in the placebo group. Those responsible for the trials then considered them sufficient. The National Institutes of Health in the US said that the results were meaningful enough.
In parallel with the successful reports from Washington, there were additional reports from China, where remdesivir was first tested for its efficacy in randomized clinical trials in Wuhan on patients in intensive care units suffering from severe cases of COVID-19.
There are now too few patients at the source of the coronavirus pandemic in Wuhan
Eventually, however, Wuhan lacked the necessary patients because of a sharp decline in new infections, and that study was also terminated prematurely, according to a report in The Lancet.
Both the early two studies, as well as the more recent published and leaked studies, seem to point to the same conclusion: The active substance remdesivir has clearly proven to be moderately effective. It reduces the death rate slightly but not significantly and it reduces the duration of the disease by a few days.
Although this is encouraging, it is far from being the resounding success that many had hoped for from what was described as the most promising drug candidate to date.
German infectious disease expert, Gerd Fätkenheuer, professor of medicine at the University Hospital Cologne, had expected a quick approval for remdesivir after the publication of the NIAID study in May. He was leading a clinical trial of remdesivir with patients in Germany.
"For patients with a severe form of this disease, this study gives hope that they will be able to recover from the infection more quickly and safely," he said. "The yardstick for the effectiveness of potential other drugs will, in the future, be remdesivir."
"The results of the large-scale SOLIDARITY study from the WHO with 11,266 patients included worldwide are not entirely unexpected, but no less disappointing" Clemens Wendtner, chief physician for infectiology and tropical medicine at the Munich Municipal Hospital said.
"Despite the limitation that no detailed data are available on the preprint server to date and a peer review process is still pending, it can be stated that the study has failed to meet its primary endpoint: None of the four drugs tested — remdesivir, hydroxychloroquine, Lopinar/Ritonavir, and IFN-ß1a - are capable of reducing COVID-19 mortality in symptomatic patients requiring hospital treatment," said Wendtler about the most recent study.
This article was originally published on April 30, 2020 — before remdesivir was approved. It has since been updated to include the latest information from recent scientific studies and the latest FDA approval.
This article was translated from German.
https://www.dw.com/en/us-fda-approves-coronavirus-drug-remdesivir-despite-doubts-about-effectiveness/a-53326847
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Anti-viral drug remdesivir has little to no effect on Covid patients' chances of survival, a study from the World Health Organization (WHO) has found.
Remdesivir was among the first to be used to treat coronavirus, and was recently given to US President Donald Trump when he was in hospital.
The drug's manufacturer Gilead rejected the findings of the trial.
In a statement, Gilead said the findings of the study were "inconsistent" with others, and that it was "concerned" that the results have yet to be reviewed.
For its Solidarity clinical trial, the WHO tested the effects four potential treatments - remdesivir, an Ebola drug, 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, suggest that none of these treatments has a substantial effect on mortality or on the length of time spent in hospital, the WHO said on Thursday.
WHO chief scientist Soumya Swaminathan said on Wednesday that their trials on hydroxychloroquine and lopinavir/ritonavir were stopped in June because they had already proven ineffective. However, the other trials continued.
The WHO's results appear to contradict a previous study from earlier this month, conducted by Gilead, which concluded that treatment with remdesivir cut Covid recovery time by five days compared to patients given a placebo. About 1,000 patients took part in that trial.
Gilead Sciences Inc dismissed the findings.
"The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomised, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir," the company said in a statement.
"We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design."
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| Gilead said it was "concerned" that the study hasn't been reviewed yet |
But Prof Martin Landray, who runs the large trial Recovery in the UK, said the results of the trial were "important but sobering" - and added that there were already concerns about the cost and accessibility of remdesivir.
"Covid affects millions of people and their families around the world," he added.
"It is not a rare disease. We need scalable, affordable and equitable treatments. The WHO Solidarity trial has done the world a huge favour by producing clear, independent and robust results, showing once more the value of large randomised trials in providing the knowledge we need to tackle the worst consequences of the pandemic."
Remdesivir was given emergency use authorisation in the US from the country's Food and Drug Administration (FDA) on 1 May. Later that month it was approved for use in the UK, and has since been authorised for use in several other countries.


Remdesivir has been touted as a potential therapy since the beginning of the pandemic and gained greater attention when it formed part of Donald Trump's cocktail of treatments.
But the WHO trial, published online, gives a damning verdict.
There is a bit of uncertainty in the data, but the study says it "absolutely excludes" the idea remdesivir can save a significant number of lives and says the findings are "comfortably compatible" with the drug having no life-saving effect at all. It is a similar message for preventing people needing ventilation or speeding up people's recovery.
So far, doctors have been raiding the cupboard for existing drugs that can fight coronavirus.
The results have been disappointing with malaria drugs, HIV drugs, MS drugs and now an Ebola drug (remdesivir). Only an old steroid - dexamethasone - has proven life-saving.
The attention is now turning to new experimental therapies such as antibodies designed in the lab to fight the virus and new, untested, anti-viral drugs.
We are still waiting for the results of these trials, but the worry is "new" in medicine tends to mean "expensive", and that will raise questions about who gets to have them.

Following the results of the Solidarity trial, Dr Swaminathan said the WHO was now "looking at what's next".
"We're looking at monoclonal antibodies, we're looking at immunomodulators and some of the newer anti-viral drugs that have been developed in the last few months," she said.
Meanwhile in China researchers say a vaccine under development has been found to be safe and to trigger immune responses in combined early and mid-stage trials.
However the researchers said it was not possible to say whether the antibody responses induced by the vaccine were sufficient to protect from infection because the trial was not designed to assess its efficacy.
Developed by the Beijing Institute of Biological Products, the vaccine has already been approved for an emergency inoculation programme in the country.
https://www.bbc.com/news/world-54566730
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