FDA issues emergency authorization to Gilead for remdesivir as possible COVID-19 treatment

May 4, 2020

The antiviral drug remdesivir was shown to shorten recovery time in some patients during clinical trials.

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization to Gilead Sciences, Inc., for a potential treatment for COVID-19.

According to a news release on the authorization, the investigational antiviral drug remdesivir was shown to shorten the time of recovery for COVID-19 in a clinical trial, though there is limited information of the safety and effectiveness in treating patients hospitalized with the disease.

“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 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” HHS Secretary Alex Azar says in the 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. The seamless cooperation between government and private industry under the president’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.”

The authorization allows the drug to be distributed in the country and administered intravenously by doctors to treat suspected or confirmed COVID-19 in children and adults with severe disease, i.e. low blood oxygen levels, in need of oxygen therapy, or on a mechanical ventilator, the release says.

The release says that it is reasonable to believe that remdesivir may be effective in treating COVID-19 and due to the lack of adequate, approved, or available alternative treatments then the known potential benefits outweigh the known and potential risks of using the drug. As part of the authorization, fact sheets must be made available to patients and physicians which contain information including dosing instructions, potential side effects, and drug interactions.

Possible side effects of remdesivir include increased liver enzymes which may indicate inflammation or damage to liver cells, and infusion-related reactions like low blood pressure, nausea, vomiting, sweating, and shivering, the release says.

“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,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, 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.”