The FDA has expanded the approved use of remdesivir (Veklury) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease, providing another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of remdesivir was limited to patients requiring hospitalization.
The FDA notes that remdesivir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.
The agency expanded the approved indication for remdesivir to include its use in adults and pediatric patients 12 years of age and older who weigh at least 40 kg with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progressing to severe COVID-19, including hospitalization or death.
The agency also revised the emergency use authorization for remdesivir to authorize the drug for treatment of pediatric patients weighing between 3.5 kg and less than 40 kg, or pediatric patients less than 12 years of age weighing at least 3.5 kg, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
Consult product labeling for remdesivir for detailed prescribing information, including potential side effects and drug interactions.
Remdesivir is a product of Gilead Sciences, Inc.
