FDA issues EUA for remdesivir to treat severe COVID-19 cases

By The Science Advisory Board staff writers

May 4, 2020 -- The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir to be used for the treatment of COVID-19. The EUA was issued to Gilead Sciences on Friday, May 1.

The emergency authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by healthcare providers to treat suspected or confirmed severe COVID-19 cases, according to the agency. Severe cases are defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support.

The authorization was evaluated based on limited safety and effectiveness information from a clinical trial (the Adaptive COVID-19 Treatment Trial). It was determined that remdesivir may be effective in treating COVID-19 -- the lack of alternative treatments and the potential benefits of treating the disease outweigh the known and potential risks of the drug's use.

Possible side effects of remdesivir include increased levels of liver enzymes -- which may be a sign of inflammation or damage to cells in the liver -- and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering. The EUA requires that information and fact sheets be made available to healthcare providers and patients.

There are currently over 15 clinical trials in various stages evaluating the use of remdesivir for COVID-19 globally.

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