Remdesivir approved for treatment of coronavirus by US authorities

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Clinical trial data shows drug reduces hospital stays in Covid-19 patients by 31 per cent

World | The Independent

An experimental anti-viral drug has been granted emergency authorisation by the US’s Food and Drug Administration (FDA) to be used to treat coronavirus.

The decision comes after a recent clinical trial showed the drug, remdesivir, improved the outcomes for patients with severe Covid-19.

The National Institutes of Health (NIH) in the US released data showing the remdesivir reduced hospitalisation stays by 31 per cent compared to a placebo treatment. However, the drug did not significantly improve chances of survival.

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Remdesivir was created by biopharmaceutical company Gilead Science, which said it will donate 1.5 million vials of the drug to help patients in hospitals in US cities hardest hit by the coronavirus. The donation is expected to be enough for at least 140,000 patients, depending on the number of days they need to be treated.

The company said due to a limited supply, hospitals with intensive care units and other hospitals the government deems most in need will receive priority.

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FDA Commissioner Stephen Hahn said during a meeting at the White House with US president Donald Trump: “It’s the first authorised therapy for Covid-19, so we’re really proud to be a part of it.”

Remdesivir was originally developed to treat Ebola. It is being tried against Covid-19 because it blocks some viruses, including the new coronavirus, from duplicating themselves and overwhelming the host’s immune system.

Denise Hinton, the FDA’s chief scientist, said in the authorisation letter there is “no adequate, approved and available alternative to the emergency use of remdesivir for the treatment of Covid-19”.

But emergency authorisations not equivalent to full FDA approval, and experts have warned that the drug should not be considered a “magic bullet” in treating coronavirus.

Virologist Stephen Griffin, from the University of Leeds, told the research journal Nature: “There is a lot of focus on remdesivir because it’s potentially the best shot we have.

“It may not be the wonder drug that everyone’s looking for, but if you can stop some patients from becoming critically ill, that’s good enough.”

Speaking in the Oval Office on Friday, Mr Trump praised the drug and called it a “very promising situation”, reported CNN.

Daniel O’Day, chief executive of Gilead Sciences, added: “We will be working very closely to get that to patients, working with FEMA, working with other parts of the government to make sure that we get that to the patients in need as quickly as possible because there are patients out there that can benefit from this medicine today that are hospitalised.

“We don’t want any time to waste for that.”

The US has the most cases and fatalities in the world at more than 1 million and at least 63,200 with much of the country in lockdown to contain the spread of the virus.

Additional reporting by agencies

  • Remdesivir approved for treatment of coronavirus by US authorities photo

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