Remdesivir Wins FDA Approval for Treatment of COVID-19 in Youngest Patients

The US Food and Drug Administration (FDA) this week expanded approval of the COVID-19 treatment remdesivir (Veklury, Gilead) to include pediatric patients aged 28 days and older, according to an administration statement.

Eligible patients must weigh at least 7 lbs with confirmed positive results of direct SARS-CoV-2 viral testing and be hospitalized or if not hospitalized, have mild-to-moderate COVID-19 symptoms and be at elevated risk for progression to severe COVID-19, including hospitalization or death.

The approval, which makes remdesivir the first COVID-19 treatment to be approved for children aged younger than 12 years, led the FDA also to revoke the emergency use authorization under which remdesivir has been available for this pediatric population since May 2020.

Under the expanded indication, according to a statement from Gilead, a 3-day course of remdesivir is recommended to help avert hospitalization in pediatric patients who are at high risk for COVID-19 diseae progression. For those patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the manufacturer recommends a 5-day treatment course.

"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, in the release. The action today, she added, confirms the agency’s commitment to that need.

Original approval of remdesivir in October 2020 was to treat adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) with COVID-19 requiring hospitalization, according to the FDA. (see sidebar)

The FDA emphasizes that remdesivir cannot replace vaccination in populations for whom COVID-19 vaccination and booster doses are recommended.

The course of COVID-19 infection in pediatric and adult patients is similar, the statement says, and so the current approval is supported, in part, by efficacy results from phase 3 clinical trials in adults (see FDA-approved product labeling for trial details).

Additional support for the pediatric indication was furnished by findings from the CARAVAN phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kg with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19. Patients received remdesivir for up to 10 days. Similar to findings for the agent’s efficacy, safety and pharmacokinetic results from the pediatric study were similar to those in adults, the release said.

The only approved dosage form of remdesivir is for injection.

Documented potential side effects of remdesivir include increased liver enzyme levels, and allergic reactions that may include changes in blood pressure and heart rate; low blood oxygen level, fever, shortness of breath, wheezing, swelling rash, nausea, sweating or shivering.

“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 at Gilead Sciences, in the company statement.