Coronavirus: United States authorizes the use of the antiviral drug Remdesivir



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Remdesivir vialsImage copyright
Reuters

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Experts warn that remdesivir should not be seen as a “magic bullet”

The United States Food and Drug Administration (FDA) has authorized the emergency use of remdesivir of the Ebola medication to treat the coronavirus.

The authorization means that the antiviral medication can now be used in people hospitalized with severe Covid-19.

A recent clinical trial showed that the drug helped shorten recovery time for people who were seriously ill.

However, it did not significantly improve survival rates.

Experts have warned that the drug, which was originally developed to treat Ebola and is produced by the pharmaceutical company Gilead in California, should not be seen as a “magic bullet” for the coronavirus.

The drug interferes with the virus’s genome, disrupting its ability to replicate.

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During a meeting with US President Donald Trump in the Oval Office, Gilead Chief Executive Daniel O’Day said that FDA clearance was an important first step.

The company would donate 1.5 million vials of the drug, he said.

FDA Commissioner Stephen Hahn also said at the meeting: “It is the first licensed therapy for Covid-19, so we are very proud to be a part of it.”

FDA emergency authorization is not the same as formal approval, which requires a higher level of review.

What do we know about remdesivir?

The drug did not cure Ebola, and Gilead says on its website: “Remdesivir is an experimental drug that has not established safety or efficacy for treating any condition.” Gilead also warns of possible serious side effects.

However, President Trump has been a vocal advocate of remdesivir as a potential treatment for coronavirus.

In its clinical trial, the US National Institute of Allergy and Infectious Diseases. USA (NIAID) found that remdesivir reduced the duration of symptoms from 15 days to 11.

The trials involved 1,063 people in hospitals around the world, including the United States, France, Italy, the United Kingdom, China, and South Korea. Some patients received the medication and others received a placebo (dummy) treatment.

Dr. Anthony Fauci, who heads the NIAID, said that remdesivir had “a clear, significant, and positive effect in decreasing recovery time.”

However, while remdesivir may aid recovery, and possibly prevent people from having to be treated in intensive care, the trials did not give any clear indication of whether it can prevent coronavirus deaths.

As there is still uncertainty about the treatment regimen, Gilead suggests a dosage duration of 10 days for patients on respirators and five days for patients who are not.

Could other countries use remdesivir?

Gilead says it is currently depleting existing stocks of the drug, and supply is limited. The US government USA It will coordinate the distribution of remdesivir to hospitals in US cities. USA Most affected by Covid-19.

Therefore, it is not clear how much of the drug could be distributed worldwide, or at what price.

Gilead says he is donating 1.5 million individual doses of remdesivir, which “equates to more than 140,000 courses of treatment to be provided at no cost.” Emergency distribution in the United States is included in that.

But worldwide there are more than three million confirmed cases, in 185 countries.

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Gilead says it strives to expand production rapidly, with global partners.

The company aims to produce at least 500,000 treatment courses in October, 1 million treatment courses in December 2020, and millions more in 2021, if needed.

The Institute for Clinical and Economic Review, a US body that studies drug prices, estimated the cost of a 10-day remdesivir course at $ 10 (£ 8), but suggested that a cost-effective price could be up to $ 4,500 , according to Clinical Trials.

New York Nursing Home Deaths

The news of the possible treatment comes when a nursing home in New York reports 98 coronavirus-related deaths.

The Isabella Geriatric Center in Manhattan said 46 of its residents died after testing positive, while the other 52 were suspected of having the virus.

And Dr. Fauci has been barred from testifying next week before a congressional committee examining the Trump administration’s response to the pandemic.

“While the Trump administration continues its government-wide response to Covid-19, including the safe opening of the United States again and streamlining vaccine development, it is counterproductive to have the same people involved in those efforts that appear in Congress”. House spokesman Judd Deere said in a statement.

In other coronavirus news:

  • Irish Taoiseach Leo Varadkar has said the country will begin lifting its blockade on May 18, “slowly and gradually.”
  • India has also extended its restrictions for two weeks after May 4
  • The World Health Organization (WHO) has defended its response to the early stages of the coronavirus outbreak in China, saying it “wasted no time”
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