European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
Roche has 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. 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.
Influenza is a serious infectious disease and represents a significant threat to public health. Rates of influenza in Europe are rising and it is expected that the virus will infect around one in four children each year. In addition to being at higher risk of infection, children also play a significant role in the spread of influenza from one person to another. In studies of influenza transmission in households, the risk of infection from others in the household was as high as 38%. Prophylactic treatment with Xofluza, which stops viral replication faster than oseltamivir, may help to limit the spread of influenza and therefore reduce the impact and burden of influenza on society.
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