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FDA Gives Remdesivir Emergency Authorization

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This story was updated May 1, 2020, with the official FDA emergency use authorization for remdesivir.

April 30, 2020 - The FDA approved an emergency use authorization for the experimental antiviral drug remdesivir to treat COVID-19.

In a news release, the FDA said "While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients."

The move allows for the drug to be given to adults and children hospitalized with severe COVID cases. The agency defined severe as patients with low blood oxygen levels, needing oxygen therapy, or breathing support such as a mechanical ventilator.

Earlier in the week, a clinical trial sponsored by the National Institutes of Health showed the drug sped up recovery time for patients with COVID-19 compared to patients who received a placebo.

The trial involving 1,063 patients showed people who took remdesivir recovered 31% faster than people who received a placebo.

The NIH also said the clinical trials “suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.”

However, a study conducted in China was less encouraging. The findings of that study, published in The Lancet, found the drug did not help patients with severe COVID-19.

More than a million cases of the pandemic have been reported in the U.S., with more than 52,000 deaths, according to Johns Hopkins University.

Read more about remdesivir for COVID19. 

WebMD Health News Brief Reviewed by Michael W. Smith, MD on April 30, 2020

Sources

Johns Hopkins University.

National Institutes of Health: NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19.

The Lancet: Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.

FDA.

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