Gilead wins approval for COVID antiviral remdesivir in young children
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The U.S. FDA has expended the indication for Gilead Sciences' (NASDAQ:GILD) antiviral medication Veklury (remdesivir) for children 12 years old to as young as 29 days old.
The expanded approval in this population is for those that are hospitalized with COVID-19, or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19.

For those that are hospitalized, a 5-day treatment course is recommended. For those who aren't but are at high risk for progression, a 3-day course is recommended.
Of the 53 pediatric patients enrolled in the phase 2/3 CARAVAN study, 75% and 85%, respectively, showed clinical improvement on day 10 and last assessment.
Veklury is now the first COVID treatment approved for children 12 and younger.
In January, the FDA expanded the use of Veklury for non-hospitalized adults and adolescents.