Coronavirus & Remdesivir — FDA Fast-Tracks for Emergency Use Following Positive Trial Results

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A lab technician inspects a filled vial of investigational coronavirus treatment drug remdesivir at a Gilead Sciences facility in La Verne, Calif., March 11, 2020. (Gilead Sciences Inc/Reuters)

The Food and Drug Administration is moving to quickly authorize the use of Gilead’s experimental anti-viral drug remdesivir as an emergency treatment for coronavirus, following news that a preliminary trial of the drug showed positive results.

A senior official in the Trump administration told the New York Times that the authorization could be announced as early as Wednesday, the same day that news of the hospital trial, conducted by the National Institute of Allergy and Infectious Disease (NIAID), was released.

NIAID, which is run by Dr. Anthony Fauci, found that of 397 patients with severe cases of Covid-19, 62 percent of those treated with remdesivir early on were discharged from the hospital, compared to 49 percent of patients who began treatment late in the onset of the virus.

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Gilead Sciences called the data from the trial “positive.” While Remdesivir was developed to fight Ebola, it has never been approved as a treatment for any disease.

“We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing,” the company said in a statement, adding that remdesivir “has not yet been demonstrated to be safe or effective for the treatment of Covid-19.”

Speaking to reporters at the White House, both Fauci and Trump expressed optimism at the findings, after results from a trial in China dampened expectations last week.

“Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Fauci said. “This is very optimistic.”

“Certainly it’s a positive, it’s a very positive event,” Trump added.

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