26th April 2022 – (Los Angeles) The U.S. Food and Drug Administration (FDA) on Monday expanded its approval of the COVID-19 treatment Veklury, also known as remdesivir, to include pediatric patients 28 days of age and older weighing at least 3 kilograms who are infected by SARS-CoV-2.
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age, said the FDA.
Veklury is approved for young children who are hospitalized, or have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, according to the FDA.
Previously Veklury was only approved to treat COVID-19 for certain adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms.
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.