August 24, 2022
As reported by Healio, the FDA has approved Xofluza, an oral medication, for children ages 5-11 who have been symptomatic for no more than 48 hours. It is also approved for post-exposure prophylaxis for those in that age group who have been in contact with someone with the flu. Though pandemic flu seasons have been mild, other news stories of COVID-19 and flu ‘twindemic’ in Australia portend a severe season ahead.
This approval is the latest in a series of FDA decisions on Xofluza in younger age groups. In 2018, the drug received okayed to treat acute uncomplicated flu in patients 12 and older, followed by expanded indication for that same group who are at high risk for influenza-related complications a year later. A decision in November 2020 expanded approval as PEP for the age group.
A miniSTONE-2 study found the medication was well-tolerated in 1–11-year-olds. Xofluza also reduced the risk of transmission in that age group considerably. It is projected to be a valuable single-dose oral treatment tool to combat influenza in children and adults.
PIDS member Pedro Piedra appears in the story saying, “Historically, school-aged children have played a significant role in the community transmission of influenza. The annual influenza vaccine continues to be the most important first step to prevent illness in children, though there can still be breakthrough cases where antiviral treatment is needed.”