The US Food and Drug Administration has announced the expansion of its approval for Gilead Sciences’ COVID-19 treatment, Veklury (remdesivir), to include pediatric patients 28 days of age and older weighing at least 3 kg (about 7 lbs). The injectable drug is intended for patients who are either hospitalized or are at high risk of progression to severe COVID-19.
With this thumbs up, Veklury is the first COVID-19 treatment approved for children less than 12 years of age. This action also serves to revoke the emergency use authorization (EUA) for Veklury that previously covered this pediatric population.
Prior to this action, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kg, or about 88 lbs) with COVID-19.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said, “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. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
According to the agency, Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended. The FDA has approved two vaccines, and three vaccines are available for emergency use, to prevent COVID-19 and the serious clinical outcomes associated with COVID-19, including hospitalization and death.
Considering the similar course of COVID-19 disease in adults compared with pediatric patients, according to the FDA, the approval of Veklury in certain pediatric patients is supported by efficacy results from Phase III adult studies. The approval also reportedly is supported by a Phase II/III, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kg (about 7 lbs) with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19.
Patients in this pediatric Phase II/III trial received Veklury for up to 10 days. The safety and pharmacokinetic results from the Phase II/III study in pediatric subjects reportedly were similar to those in adults.
Possible Veklury side effects include 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.