Written By: Longjam Dineshwori | Updated : April 27, 2022 10:53 AM IST
The U.S. Food and Drug Administration (FDA) has expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms. According to a statement from the agency, the treatment could be given to children with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death. With this approval, Veklury has become the first COVID-19 treatment approved for children less than 12 years of age.
Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral drug developed by Gilead Sciences Inc. It was originally developed to treat hepatitis C, and was subsequently investigated for Ebola virus disease and Marburg virus infections, before it was approved or authorized for emergency use to treat COVID 19.
Initially, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms) with COVID-19.
"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, M.D., director of the FDA's Center for Drug Evaluation and Research.
"Today's approval of the first COVID-19 therapeutic for this population demonstrates the agency's commitment to that need," she added.
The agency noted that the approval of the treatment in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults, given the similar course of COVID-19 disease in adults and children.
The information on the trials in adults can be found in the FDA-approved drug labeling for Veklury, it said.
Additionally, the approval is supported by a phase 2/3 clinical study that included 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms with mild, moderate or severe COVID-19 infection. In this trial, the pediatric patients were given Veklury for up to 10 days. The safety and pharmacokinetic results from the pediatric study were found to be similar to those in adults.
The FDA mentioned that administration of Veklury may lead to some side effects such as increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.
However, the agency noted that Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended. It has urged people to get vaccinated and receive a booster when eligible.
