FDA gives emergency approval of drug in early trials for COVID-19 treatment

The U.S. Food and Drug Administration issued an emergency use authorization of the antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19

Posted: May 1, 2020 2:25 PM
Updated: May 1, 2020 2:37 PM

WASHINGTON, D.C. — On Friday the U.S. Food and Drug Administration (FDA) issued an emergency use authorization of the drug remdesivir for treatment of coronavirus patients. Though the drug is still only in early trials for treating COVID-19, National Institutes of Health director Dr. Anthony Fauci heralded the results as "clear-cut evidence that [the] drug works."

In clinical trials, the antiviral remdesivir appeared to shorten recovery time in some coronavirus patients, but the FDA said that there is "limited information known" about the drug's safety and effectiveness.

Nonetheless, the FDA's approval allows it to be used intravenously for the treatment of suspected or confirmed COVID-19 in both adults and children hospitalized with severe cases of the disease.

"Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator," the FDA said in a statement.

A clinical trial from the National Institutes of Health found that patients treated with remdesivir recovered 31 percent faster than those who received a placebo. The trial involved 1,063 patients, who were given the drug or placebo through a daily infusion over the course of 10 days. 

The FDA issued a similar approval for the malaria drugs hydroxychloroquine and chloroquine, which were likewise in the early stages of vetting for use on COVID-19 patients. The agency has since voiced concern that the drugs are being used "inappropriately" to treat patients who have not been hospitalized.

"We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible," the FDA said of the malaria drugs. "These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening."

The NIH trial of remdesivir began in late February, while an equivalent trial on hydroxychloroquine did not begin until early April and has yet to produce results.

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