Remdesivir Fact Sheet
Remdesivir is an investigational antiviral medication used to treat patients with COVID-19. There is limited information on the safety and effectiveness of using remdesivir to treat people with COVID-19. However, it was shown in a clinical trial to shorten the recovery time in some people. This is why the Food and Drug Administration (FDA) has authorized the emergency use of the medication for treatment.
What Is an Emergency Use Authorization (EUA)?
The United States FDA has made remdesivir available under an emergency use authorization, or an EUA. An EUA allows unapproved medical products or unapproved uses of medical products to be utilized in an emergency situation, such as the COVID-19 pandemic, to diagnose, treat or prevent serious or life-threatening diseases or conditions.
Remdesivir has not undergone the same type of review as an FDA-approved or cleared product. The FDA may issue an EUA for many different reasons, like when there are no adequate, approved, or available alternatives. In addition, the FDA decision is based on all the scientific evidence available. If science shows that it is reasonable to believe the product meets certain criteria for safety, performance, and labeling, and may be effective in treating patients during the COVID-19 pandemic, then the product can be used.
How Does It Work?
Remdesivir is given to a patient through IV once per day for up to 10 days, depending on how critically ill the patient is. According to the FDA, the medication may help decrease the amount of coronavirus in your body, which may help you get better faster. However, the safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing clinical trials
What Other Treatment Choices Are There?
In addition to remdesivir, FDA granted emergency use to two monoclonal antibody treatments, bamlanivimab and Regeneron in November 2020. These medicines can be used to treat symptomatic COVID-19 positive individuals who not yet need to be hospitalized. Your healthcare provider may talk with you about clinical trials you may be eligible for.
In Pennsylvania, you can choose whether you are treated with remdesivir, bamlanivimab, or Regeneron. If you decide not to receive it or want to stop receiving it at any time, it will not change your standard medical care.
Resources for More Information
For more information, visit https://www.health.pa.gov/topics/disease/coronavirus/Pages/Coronavirus.aspx
For more information on remdesivir, view the FDA's fact sheet
For more information on monoclonal antibody bamlanivimab, view the FDA's fact sheet
For more information on monoclonal antibody Regeneron, view the FDA's fact sheet
Report side effects to FDA MedWatch at
www.fda.gov/medwatch or call 1-800-FDA-1088.
Contact the Crisis Text Line by texting PA to 741-741
Date created: 5/15/2020; Date updated: 1/5/2021