FDA Approves Roche’s Influenza Treatment for Use in Young Children

Roche announced on August 12, 2022 that FDA has approved a supplemental New Drug Application for Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 who have been symptomatic for no more than 48 hours. FDA also approved the treatment for prevention of influenza in children of this age group following contact with someone with influenza.

According to a company press release, baloxavir marboxil is the first single-dose oral influenza medicine approved in the US for children in this age group. Prior to this announcement, the medicine was also approved for use in people aged 12 and older who are otherwise healthy or at high risk of developing influenza-related complications.

“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, chief medical officer and head of Global Product Development. Roche, in the press release. “[Baloxavir marboxil] 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.”