The Food and Drug Administration has approved Roche’s Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged 5 years old to less than 12 years old who have been symptomatic for no more than 48 hours.
This marks the first single dose oral influenza medicine approved for children in this age group. Additionally, the FDA-approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged 5 years old to less than 12 years old following contact with someone with influenza.
“Despite the ongoing COVID-19 pandemic, influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems,” said Levi Garraway, Roche’s chief medical officer and head of global product development. “Xofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents, and we are pleased to now offer households and younger children our single-dose oral treatment.”
According to the Centers for Disease Control and Prevention, influenza can be a serious illness for young children. During the ongoing COVID-19 pandemic, there have been significantly fewer influenza cases, likely due in large part to social distancing and mask wearing. However, in the 2018-2019 influenza season, there were more than 6 million illnesses, thousands of hospitalizations and over 100 deaths among children aged 5 to 17 years old caused by influenza, Roche said.
“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,” said Pedro Piedra, miniSTONE-2 study investigator and professor of molecular virology, microbiology and pediatrics at Baylor College of Medicine. “Today’s FDA approval provides children with a single-dose antiviral option, Xofluza, to treat influenza.”
Xofluza already is FDA approved to treat influenza in people aged 12 years old and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.
Xofluza also is approved to prevent influenza in people aged 12 years old and older, following contact with someone with influenza (known as post-exposure prophylaxis).