FDA working to authorize drug for COVID-19 patients that was part of LI trial

The Food and Drug Administration is reportedly working at "lightning speed" to sign off on a COVID-19 drug that was part of a trial on Long Island.

News 12 Staff

Apr 30, 2020, 9:08 PM

Updated 1,505 days ago

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The Food and Drug Administration is reportedly working at "lightning speed" to sign off on a COVID-19 drug that was part of a trial on Long Island.
FDA emergency authorization of the drug remdesivir is going to happen "really quickly," according to Dr. Anthony Fauci.
Officials with the Feinstein Institutes for Medical Research, the research arm of Northwell Health, announced they were conducting two clinical trials of the drug late last month.
Feinstein Institute President and CEO Dr. Kevin Tracy said back when the announcement was made that, "The hope is these two trials, which are both intravenous drugs, will be given in the ICU or to critically ill people and hopefully have some of them turn around."
Tracey said one clinical trial targets patients who appear moderately ill with the virus, while the other is for patients in the ICU with lung failure and low oxygen levels.
A study done by the National Institutes of Health gave more than 1,000 patients either remdesivir or a placebo. Fauci says those on the placebo recovered in 15 days, compared to an 11-day recovery for patients on remdesivir.
"The improvement was a 31% better chance of recovering and getting out of the hospital," says Fauci. "That's important, but it's the first step in what we project will be better and better drugs coming along."
FDA officials haven't said exactly when they will sign off on the authorization, or given a timeline as to when they would allow the drug to hit the market.
 


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