European Commission approves Xofluza in young children
The European Commission (EC) has approved Xofluza (baloxavir marboxil) in children aged one year and older.
Developed by Swiss pharma giant Swiss pharma giant Roche (ROG: SIX), Xofluza is intended for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. Post-exposure prophylaxis aims to prevent flu in individuals following contact with someone infected with the influenza virus. The approval comes at a time when fears of a ‘twindemic’ have been realised as Covid and flu cases rise.
The Commission’s decision is based on the results of the Phase III miniSTONE-2 and BLOCKSTONE studies. This approval marks the first single-dose, oral influenza medicine approved in Europe for children, and now means that Xofluza can be used to treat and prevent uncomplicated influenza in children aged one year and above, and in adolescents and adults.
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