On Aug. 11, 2022, Roche announced that the U.S. Food and Drug Administration (FDA) had approved a supplemental New Drug Application (sNDA) for Xofluzaﾮ (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.

This marked the first single-dose oral influenza medicine approved in the US for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.