FDA to clear Gilead's emergency coronavirus treatment: Report

Patients given remdesivir recovered faster, had lower mortality rate

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The Food and Drug Administration is reportedly planning to authorize the emergency use of the experimental drug remdesivir for COVID-19 treatment.

The FDA could announce Gilead Sciences’ drug for emergency use as early as Wednesday, The New York Times reported.

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GILEAD SEES ‘POSITIVE’ DATA ON CORONAVIRUS TREATMENT REMDESIVIR TRIAL

A trial found that COVID-19 patients given remdesivir “recovered faster” than patients given a placebo, the National Institute of Allergy and Infectious Diseases announced Wednesday.

Dr. Anthony Fauci, the White House infectious diseases expert, called the study “very optimistic” but noted it has not yet been peer-reviewed, the Times reported.

A vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. (Gilead Sciences via AP)

WHAT IS REMDESIVIR?

The controlled trial involved more than 1,000 patients across 68 sites beginning on Feb. 21, officials said. Preliminary results show patients given remdesivir recovered 31 percent faster, with a median recovery time of 11 days with the drug compared to 15 without it. Patients given remdesivir also had a lower mortality rate, 8 percent, compared to 11.6 percent for patients not given the drug.

Earlier, the National Institute of Allergy and Infectious Diseases also said a study of the drug in monkeys also showed “significantly better health” for monkeys infected with COVID-19 that were treated with the drug.

However, another trial for the drug in China reportedly "failed."

Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material. (Gilead Sciences via AP)

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The coronavirus has infected more than 1 million people and killed more than 59,000 people in the United States.

The FDA has been using emergency use authorizations in order to “provide more timely access” to drugs, tests and other needed medical products for combatting the coronavirus.

“When deciding whether to issue an EUA, the FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public,” the agency said Tuesday.

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