The U.S. Food and Drug Administration (FDA) announced earlier this week that it was approving Gilead Sciences'
According to the FDA's announcement, the newly expanded approval of remdesivir applies to patients as young as 28 days that are at least 7 pounds in weight. Previously, the antiviral had only been cleared for use on children as old as 12, weighing at least 88 pounds.
"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," Dr. Patrizia Cavazonni, director of the FDA's Center for Drug Evaluation and Research, noted in the announcement. "Today's approval of the first COVID-19 therapeutic for this population demonstrates the agency's commitment to that need."
It's worth noting that remdesivir's expanded clearance is mainly intended as a stopgap measure for young patients who either cannot receive a vaccine for health reasons or are not yet old enough to receive one. The FDA doesn't recommend remdesivir as a substitute for vaccines and has noted that vaccinations remain the best option against COVID-19 for individuals who are healthy enough to receive one.
The FDA's expanded approval comes as the field of medicines has been gradually narrowed due to waning efficacy against emerging COVID-19 strains. In January, the FDA withdrew its authorization for monoclonal antibody treatments made by Eli Lilly
The expanded approval doesn't seem to have had too much positive effect on Gilead's shares, with the firm ending 0.64% up on Monday. Shares slid an additional 2.9% by noon on Thursday.
