The FDA has authorized emergency use of the Ebola drug remdesivir for treating the coronavirus.
The authorization means the anti-viral drug can now be used on people who are hospitalized with severe Covid-19.
A recent clinical trial showed remdesivir helped shorten the recovery time for people who were seriously ill.
However, the drug did not significantly improve survival rates.
Experts have warned remdesivir – which was originally developed to treat Ebola, and is produced by Gilead pharmaceutical company in California – should not be seen as a “magic bullet” for coronavirus.
Remdesivir interferes with the virus’s genome, disrupting its ability to replicate.
During a meeting with President Donald Trump in the Oval Office, Gilead Chief Executive Daniel O’Day said the FDA authorization was an important first step.
Gilead would donate 1.5 million vials of the drug, he said.
FDA Commissioner Stephen Hahn also said at the meeting: “It’s the first authorized therapy for Covid-19, so we’re really proud to be part of it.”
Emergency FDA authorization is not the same as formal approval, which requires a higher level of review.
Remdesivir did not cure Ebola, and the producing company says on its website: “Remdesivir is an experimental medicine that does not have established safety or efficacy for the treatment of any condition.”
Gilead also warns of possible serious side-effects.
However, President Trump has been a vocal supporter of remdesivir as a potential treatment for the coronavirus.
In its clinical trial, whose full results are yet to be released, the US National Institute of Allergy and Infectious Diseases (NIAID) found that remdesivir cut the duration of symptoms from 15 days down to 11.
The trials involved 1,063 people at hospitals around the world – including the US, France, Italy, the UK, China and South Korea. Some patients were given the drug and others were given a placebo (dummy) treatment.
Dr. Anthony Fauci, who runs NIAID, said that remdesivir had “a clear-cut, significant, positive effect in diminishing the time to recovery”.
However, although remdesivir may aid recovery – and possibly stop people having to be treated in intensive care – the trials did not give any clear indication whether it can prevent deaths from coronavirus.
As much remains uncertain about the treatment regime, Gilead suggests a 10-day dosing duration for patients on ventilators and five days for patients who are not.
The FDA’s jurisdiction does not stretch overseas so the authorization only applies to US. Experts also stressed that the emergency use is not the same as full approval.
American medical community has lambasted President Donald Trump for suggesting research into whether coronavirus might be treated by injecting disinfectant into the body.
The president also appeared to propose irradiating patients’ bodies with UV light, an idea dismissed by a doctor at the briefing.
Another of the president’s officials had moments earlier said sunlight and disinfectant were known to kill the infection.
Disinfectants are hazardous substances and can be poisonous if ingested.
Even external exposure can be dangerous to the skin, eyes and respiratory system.
During April 23 White House coronavirus task force briefing, an official presented the results of US government research that indicated coronavirus appeared to weaken more quickly when exposed to sunlight and heat.
The study also showed bleach could kill the virus in saliva or respiratory fluids within five minutes and isopropyl alcohol could kill it even more quickly.
William Bryan, acting head of the Department of Homeland Security’s Science and Technology Directorate, outlined the findings at the news conference.
While noting the research should be treated with caution, President Trump suggested further research in that area.
He said: “So, supposing we hit the body with a tremendous – whether it’s ultraviolet or just very powerful light.”
“And then I said, supposing you brought the light inside of the body, which you can do either through the skin or in some other way. And I think you said you’re going to test that too. Sounds interesting,” he continued.
“And then I see the disinfectant where it knocks it out in a minute. One minute. And is there a way we can do something like that, by injection inside or almost a cleaning?
“So it’d be interesting to check that.”
Pointing to his head, President Trump went on: “I’m not a doctor. But I’m, like, a person that has a good you-know-what.”
The president turned to Dr. Birx and asked if she had ever heard of using “the heat and the light” to treat coronavirus.
“Not as a treatment,” she said.
“I mean, certainly, fever is a good thing. When you have a fever, it helps your body respond. But I’ve not seen heat or light.”
“I think it’s a great thing to look at,” President Trump said.
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