FDA approves first COVID-19 treatment for young children

The FDA has expanded the approval of the COVID-19 treatment, Veklury (remdesivir), to include pediatric patients 28 days of age and older, with positive results of direct SARS-CoV-2 viral testing. The move makes Veklury the first approved COVID-19 treatment for children less than 12 years of age.

The expanded approval includes only patients weighing at least 3 kilograms (roughly 7 pounds), who are hospitalised, or not hospitalised and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalisation or death.

As a result of the approval action, the agency also revoked the emergency use authorisation (EUA) for Veklury that previously covered this paediatric population.

“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, MD, 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.”

Before the announcement, Veklury was only approved to treat certain adults and paediatric patients (12 years of age and older, who weigh at least 40 kilograms, which is about 88 pounds), with COVID-19.

The FDA emphasised in a press release that “Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended,” and also urged the public to receive vaccination and booster jabs when eligible.

“The expanded indication for Veklury for the treatment of children is a testament to the safety, tolerability and efficacy profile of this therapy, which has remained the foundational antiviral for COVID-19 treatment,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Effective and tolerable options for children require our best science and a dedicated focus. With the recent opening of our Gilead Pediatric Center of Excellence in Dublin, which is responsible for coordinating pediatric clinical trials for treatments for HIV, hepatitis B and COVID-19, we will continue our research to help address unmet treatment needs for children.”

Ana Ovey