FDA on May 1st 2020 issued an EUA to Gilead Sciences Inc. for the investigational antiviral drug
remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children
hospitalized with severe disease. This was on the basis of the National Institutes of Health’s
clinical trial that showed promising results in use of the drug and is a significant step forward
in battling COVID-19. The emergency use authorization allows for remdesivir to be distributed in
the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected
or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The FDA
also defines “severe disease” as patients with low blood oxygen levels or needing oxygen therapy or
more intensive breathing support such as a mechanical ventilator.
While there is limited information known about the safety and effectiveness of using remdesivir to
treat people in the hospital with COVID-19, the drug was shown in a clinical trial to shorten the time
to recovery in some patients. 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 will be effective 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 and may be
revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.