US authorises use of anti-viral drug remdesivir for coronavirus patients

WHAT IS REMDESIVIR AND DOES IT WORK AGAINST CORONAVIRUS?

WHAT IS REMDESIVIR AND DOES IT WORK AGAINST CORONAVIRUS?

With over one million infection cases in the USA and at least 63,019 deaths according to Johns Hopkins University, President Donald Trump has endorsed the effectiveness of using remdesivir to treat COVID-19.

There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19.

However, it did not significantly improve survival rates.

Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is created to disable the mechanism by which certain viruses make copies of themselves and potentially overwhelm their host's immune system.

"These two rigorously done trials provide really the first evidence of the efficacy of any therapeutic for this disease", said Lloyd Minor, dean of the Stanford School of Medicine.

Gilead on Thursday said it can produce several million doses of the drug in 2021.

The FDA authorization applies to patients hospitalized with severe COVID-19 who require oxygen supplementation. The special permit for the United States of America that has now been issued does not yet correspond to any formal approval, since this is a much more complex process.

What do we know about remdesivir?

Side effects such as deterioration in liver and kidney functions are feared.

Tracy Taylor breaks down the advances that scientists have made with remdesivir, which the FDA could be approving soon for coronavirus treatment.

Already responsible for a series of strong Wall Street rallies, the antiviral drug remdesivir undergoing trials as a treatment for COVID-19 got a huge shot in the arm Wednesday from Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID).

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In vitro testing by Gilead Sciences has demonstrated remdesivir is active against SARS-CoV-2.

"The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recover", Fauci said to White House press reporters Wednesday. In all, over 180,100 people have recovered from the epidemic. "They will begin shipping tens of thousands of treatment courses out early this week and be adjusting that as the epidemic shifts and evolves in different parts, in different cities here in the United States", O'Day said on Sunday.

The FDA's jurisdiction does not stretch overseas so the authorisation only applies to US. Because it received special approval in the US and can now also be used officially in the fight against the corona virus.

"It's an IV drug at this time and can't be given outside the hospital", Ajuja said.

The COVID-19 pandemic has taken the world by storm with over 3.3 million positive cases globally.

So it is not clear how much of the drug could be distributed worldwide, nor at what price. The emergency distribution in the USA is included in that.

Aaron Kesselheim, a Harvard Medical School professor who studies drug pricing, told the New York Times that as the government funded the research showing remdesivir's value, it "doesn't seem fair" for Gilead to take all the rewards.

Despite these questions, Gilead has been ramping up production.

O'Day continued: "There is still more work to do and remdesivir has not been approved, but all of us at Gilead are humbled by what these promising results might mean for patients".

The Secretary of Health and Human Services, Alex Azar, described it as "an important step forward in the fight against COVID-19".

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