Editor’s note: This post first published on May 15, 2020 and has been updated with new information announced by the FDA on October 23, 2020.
The U.S. Food and Drug Administration (FDA) has announced the approval of remdesivir (Veklury®) for the treatment of hospitalized COVID-19 adults and children of a specific age and weight. Before now, remdesivir was used by U.S. providers for hospitalized COVID patients under an Emergency Use Authorization (EUA). The difference between the FDA approval and the FDA EUA, is that the FDA has determined there is now enough evidence to indicate that the drug is both safe and effective for treatment of COVID-19.
Despite this FDA approval, researchers continue to seek answers to questions about remdesivir and many clinical trials are still ongoing. This does, however, represent a big change as this is the first and only drug with FDA approval available for use in the fight to treat COVID-19.
To help you better understand the latest news surrounding remdesvir, Logan Whitfield, PharmD, Marshfield Clinic Health System pharmacy antimicrobial stewardship coordinator, answers these questions:
Will the FDA approval of remdesivir change how providers use it as a COVID-19 treatment?
“The FDA approval does little to change which patients providers will consider for remdesivir treatment,” Whitfield said. “Even before FDA approval, the drug has been in sufficient supply for Marshfield Clinic Health System patients.”
Will more COVID-19 patients be given remdesivir because of the FDA’s approval?
“No, in fact the FDA approval was only for treatment of COVID-19 in hospitalized adults and children at least twelve years of age and weighing at least 88 pounds,” Whitfield said. “The FDA altered the EUA to cover younger and smaller children, highlighting that there is little data in this patient population.”
Will the FDA be approving more drugs for COVID-19 treatment?
Whitfield notes that the FDA is continually reviewing new drug applications (NDAs) as more and more clinical studies are completed and published.
To learn more about what the FDA is doing to combat COVID-19 disease, visit the FDA website.
Are there other promising drugs that in the horizon regarding COVID-19?
While there are no specific COVID-19 drugs that are nearing FDA approval, Whitfield said hundreds of clinical trials are ongoing.
For further information, you may also consider discussing this drug with your health care provider.