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May 1, 2020: FDA Issues Emergency Use Authorization for Possible COVID-19 Treatment

On May 1, 2020, The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the antiviral drug remdesivir to be used as a potential treatment for coronavirus (COVID-19). This allows for hospitals and healthcare facilities to use remdesivir on patients, both children and adults, with suspected or confirmed coronavirus and severe 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.

Remdesivir Information

The FDA advises that while there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, a clinical trial has shown that it seems to shorten recovery time in some patients. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA has determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19. Given there are currently no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious and/or life-threatening virus currently outweigh the known and potential risks of the using remdesivir.

Emergency Use Authorization Information

An EUA is different than full FDA approval; In deciding whether to issue an EUA, the FDA considers the available evidence and carefully balances any known or possible risks of the unproven product(s) with any known or possible benefits of making it available during the emergency.

The EUA was issued to Gilead Sciences Inc. The FDA had previously approved the study of remdesivir under clinical trials, as well as expanded access for individual patients and through a multi-patient expanded access program coordinated by Gilead.

The FDA has advised that the EUA will remain in effect until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. Further, it may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

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