FDA Issues EUA for Investigational Antiviral Drug Remdesivir

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The investigational antiviral drug remdesivir was issued an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of suspected or laboratory-confirmed coronavirus disease 2019 (COVID-19) in patients hospitalized with severe disease.

The EUA, issued to Gilead Sciences, Inc, comes 2 days after the National Institutes of Health (NIH) announced positive results of the first randomized, placebo-controlled trial of remdesivir.

With the EUA, remdesivir can now be distributed in the US and administered intravenously by health care providers to treat adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support (eg, mechanical ventilator).

“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD, in the FDA press release on May 1, 2020.

Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective.

After evaluating the EUA criteria, the FDA determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given the fact there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat COVID-19 outweigh the potential risks of its use.

The EUA also requires fact sheets be made available to health care providers and patients so they can become educated on the important information about using remdesivir to treat COVID-19.

Possible side effects of remdesivir include:

• Rising levels of liver enzymes (may be a sign of inflammation or damage to liver cells)
• Infusion-related reactions (may include low blood pressure, nausea, vomiting, sweating, and shivering)

“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19,” said Commissioner Hahn in the FDA release, “and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.”

The FDA previously allowed for study of the investigational antiviral under clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by manufacturer Gilead Sciences.

“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19,” said Department of Health and Human Services Secretary Alex Azar, in the same FDA press release. “NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19.”