FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19.
The indication is limited to children who are either hospitalized or have a high risk of developing severe COVID-19, including hospitalization or death.
In October 2020, remdesivir became the first FDA-approved COVID-19 treatment and is now the first drug to win approval for children under 12 years of age.
Remdesivir was formerly authorized for use in young children under emergency use authorization but was FDA-approved for COVID-19-infected individuals at least 12 years old who weigh at least 40 kg (roughly 88 lb).
“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 Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
FDA noted in a press release that remdesivir is not intended to be a substitute for vaccination.
Gilead won the approval after submitting data from the Caravan Phase 2/3 single-arm, open-label study. The trial showed that remdesivir was generally well-tolerated in hospitalized patients and accelerated clinical improvement and recovery. Studies in adults have reached similar conclusions.
In early afternoon trading, GILD shares were down almost 1% to $62.09.