Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above

Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adultsXofluza is the first influenza antiviral with a new mechanism of action in almost 20 years, stopping viral replication faster thanoseltamivirSingle-doseXofluza helps reduce the societal burden of influenza by helping patients recover quickly and by preventing infection in individuals following contact with someone with the virusBasel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza ® (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The Commission ’s Decision is based on the results of the phase III miniSTONE-2 and BLOCKSTONE studies.1,2 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.3“We are delighted that the European Commission has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children,” said Levi Garraway, M.D....
Source: Roche Media News - Category: Pharmaceuticals Source Type: news