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Charley Lanyon

The US Food and Drug Administration is expected to announce approval for the emergency use of a new experimental drug after trials showed it is effective in treating Covid-19.
The biopharmaceutical firm Gilead Sciences said on Wednesday that clinical trials had shown its antiviral drug remdesivir improves outcomes for coronavirus patients.
According to Gilead, a trial on patients with severe cases of Covid-19 found that 62 per cent of them treated early with remdesivir were discharged from the hospital, compared with just 49 per cent of patients who were treated later. In a government-run trial, patients given remdesivir had a 31 per cent faster recovery time than those who received a placebo.
Remdesivir disables the mechanism by which viruses replicate themselves and overwhelm their host’s immune system.


It was unclear Wednesday evening when the announcement about remdesivir’s emergency authorisation would be made, but the trials had been closely watched, and the anticipated announcement both moved the stock markets during the day – with broader markets rising and Gilead shares soaring 5.7 per cent – and garnered a response from Washington.
US President Donald Trump hailed the findings Wednesday morning while top infectious-disease official Dr Anthony Fauci offered a more measured response, calling the findings “highly significant”. Even so, Fauci said that the new drug would likely become the new “standard of care” in treating the virus.
“The data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. This is really quite important,” Fauci told reporters at the White House. “The FDA, literally as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it.”
US Health and Human Services Secretary Alex Azar cited preliminary findings from a controlled trial of the medication by the US National Institutes of Health (NIH) on more than 1,000 Covid-19 patients as “a beacon of hope for all Americans and everyone around the world waging war on the COVID-19 pandemic”.
Still, Fauci cautioned that research on remdesivir’s efficacy was in the early stages: “Bottom line – you're going to hear more details about this. This will be submitted to a peer reviewed journal, and will be peer reviewed appropriately.”


According to the FDA website, an emergency use authorisation “may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases”.
Gilead released information on two separate trials, and said that the trial conducted by the National Institute of Allergy and Infectious Diseases – the NIH agency that Fauci leads – had met its goal of demonstrating that the drug is effective in helping patients with Covid-19.
That is especially significant as that trial compared patients who took remdesivir with those who took a placebo, definitively demonstrating that the drug is effective.
The other study, which did not use a group treated with a placebo, traced the treatment’s effectiveness in patients from dozens of medical centres. That study also found that the drug was effective and that patients treated with it were discharged earlier than those who were not.
Results of a third study, testing the drug on patients with milder cases of the disease, are expected in late May.
Did Gilead’s miracle drug work or flop? Analysts aren’t quite sure
The good news came after days of confusion surrounding the drug, with Gilead, based in Foster City, California, on the defensive against accusations that remdesivir – which was also tested unsuccessfully in the treatment of Ebola – was ineffective against Covid-19.
Scepticism about the drug ramped up after the World Health Organisation accidentally released findings last week of a Chinese trial that had found remdesivir failed to improve patients’ condition or even reduce evidence of the virus in the bloodstream. The findings of that trial were published on Wednesday in the British medical journal The Lancet.
Gilead as well as US health experts dismissed that trial, though, saying its findings were tarnished because it was terminated early due to poor enrolment.


The preliminary data from the Gilead trials are expected to be unveiled soon, with the trial's official results coming by mid-May and preliminary findings likely even earlier, according to its lead researcher.
“The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” Gilead’s chief medical officer, Merdad Parsey, said in a statement.
Dr Peter Chin-Hong, an infectious-disease specialist at the University of California, San Francisco, where he is the principal investigator for a remdesivir expanded-access programme, said that more study is necessary before anyone can be sure about the drug’s efficacy, but that his personal experiences have been heartening:
“As a human being and not a scientist, I feel that my patients have done really well [on remdesivir]. The first patient I had with COVID-19 ever … was somebody in his 40s who was very ill. We were able to get him remdesivir and he walked out of the ICU.”

“Just last week we had another patient who was transferred into our system from another health care facility because they didn't have access to remdesivir. So we were able to get her remdesivir, and she went from being on a breathing tube to being on a very minimal amount of oxygen – today just one litre.”
Chin-Hong noted that “having effective treatments for virus infections is not only important for treating the individual patient, it could have community benefits as well because it helps reduce the amount of virus in the community”.
Antivirals which limit the ability of the virus to multiply means “that person you're treating is probably going to be less likely to transmit it to somebody else”, he said.
Trials for Gilead coronavirus drug far from reaching enrolment target
Other trials of the drug have also been successful.
The health and medical news website Stat reported on April 16 that a Chicago hospital using remdesivir to treat severe Covid-19 patients saw rapid recoveries in fever and respiratory symptoms, with most patients discharged within a week.
Dr Kim Woo Joo, who led South Korea’s response to Covid-19 and the outbreak of Mers in 2015, echoed the optimism about the new treatment and others like it: “If everything goes well, I am hoping that the effectiveness of these drugs will be scientifically proven within three to four months.”
Additional reporting by Reuters


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Food and Drug Administration seen to allow emergency use of Gilead Sciences’ experimental drug after clinical trials show its effectiveness
US President Donald Trump hails data as good news, though top disease expert Anthony Fauci says results need to be further analysed


Food and Drug Administration seen to allow emergency use of Gilead Sciences’ experimental drug after clinical trials show its effectiveness.


US expected to approve use of remdesivir after trials show it helped coronavirus patients

Food and Drug Administration seen to allow emergency use of Gilead Sciences’ experimental drug after clinical trials show its effectiveness US President Donald Trump hails data as good news, though top disease expert Anthony Fauci says results need to be further analysed

Food and Drug Administration seen to allow emergency use of Gilead Sciences’ experimental drug after clinical trials show its effectiveness

US President Donald Trump hails data as good news, though top disease expert Anthony Fauci says results need to be further analysed