At a time when effective therapies against the Omicron and Delta variants are in high demand, the U.S. Food and Drug Administration (FDA) recently approved Veklury (Remdesivir) to treat non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19, including hospitalization or death. This approval expands the role of Veklury, which is the antiviral standard of care for treating patients hospitalized with COVID-19. The drug had previously been limited to hospitalized patients.
Additionally, the FDA expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who test positive for COVID-19 and are at high risk for progression to severe COVID-19.
Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. Eligible American Indians and Alaska Natives are to get vaccinated and received booster to help protect their communities. Vaccination prevents serious outcomes related to COVID-19, including hospitalization and death. If you have been vaccinated continue to show an Act of Love by wearing a mask to help keep elders, young children, your community, and yourself healthy.
- Remdesivir EUA Letter of Authorization
- Frequently Asked Questions for Veklury (Remdesivir)
- Emergency Use Authorization: Drugs and Non-Vaccine Biological Products
- Coronavirus Treatment Acceleration Program (CTAP)
- Coronavirus Disease (COVID-19)