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FDA may fast-track experimental coronavirus drug

A clinical trial shows remdesivir helps some patients recover faster

Photo (c) boyisteady - Getty Images
President Trump says the Food and Drug Administration (FDA) should approve Gilead Science’s experimental drug remdesivir as soon as it can so that it can be used to treat coronavirus (COVID-19) patients.

The FDA is reportedly planning to do just that. The New York Times reports that the agency is preparing to issue emergency authorization for the drug, and that step could come as early as Wednesday. The FDA told CNN that it is in talks with Gilead Science about steps that could be taken to make remdesivir available to coronavirus patients. 

The catalyst is a clinical trial conducted by the National Institute for Allergy and Infectious Disease (NIAD), which found that the drug speeded up the recovery time for patients taking the drug compared to those taking a placebo.

Dr. Anthony Fauci, NIAD’s director, told attendees at a White House meeting on Wednesday that he’s optimistic the drug can be an effective weapon against the virus.

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Fauci said during a meeting with President Trump. "This is highly significant."

Reduced recovery time

Results from the preliminary trial show that the antiviral drug reduced recovery time for coronavirus patients from 15 to 11 days. The influenza drug Tamiflu has a similar effect on the flu. 

The study found that remdesivir reduced the period of time it took a hospital patient with the coronavirus to recover, compared with a placebo. The study defined "recovery" as being well enough to leave the hospital or return to normal activity.

"Although a 31 percent improvement doesn't seem like a knockout 100 percent, it is a very important proof of concept," Fauci said. "What it has proven is that a drug can block this virus."

The primary effect of remdesivir is that it prevents the coronavirus from replicating. Fauci  compared remdesivir to early drugs against HIV. They were somewhat effective but were improved over time as scientists learned how they worked in the human body.

Results from the trial were not expected to be released until late May, but Fauci said when the preliminary findings are this positive “you have an ethical obligation to immediately let the people in the placebo group know so that they can have access."

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