Roche’s Xofluza (baloxavir marboxil) has been approved by the European Commission (EC) to treat and prevent uncomplicated influenza in children aged one year and over.
With the EC’s decision, Xofluza is now the first single-dose, oral influenza medicine approved in Europe for children.
The approval was based on phase 3 trial results taken from miniSTONE-2, which assessed the use of Xofluza in children, and BLOCKSTONE, which assessed Xofluza in both adults and children as a preventive treatment for households.
The miniSTONE-2 study met its primary endpoint of safety and demonstrated that Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir.
Time to alleviation of influenza signs and symptoms were comparable between Xofluza and oseltamivir, Roche reported, at 138 hours and 150 hours, respectively.
In the BLOCKSTONE study, Xofluza demonstrated a statistically significant prophylactic effect after a single oral dose, by reducing the risk of developing influenza after exposure to an infected household member by 86% versus placebo.
Commenting on the decision, Levi Garraway, Roche’s chief medical officer and head of global product development, said: “We are delighted that the EC has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children.
“We are hopeful that Xofluza’s convenient single-dose oral regimen will help children recover quickly, as well as reduce the societal burden of influenza.”
Rates of influenza in Europe are rising and it is expected that the virus will infect around one in four children each year. As well as being at higher risk of infection, children also play a significant role in the spread of influenza from one person to another.
Xofluza was first approved for use in Europe in 2021 for the treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in adults and adolescents aged 12 years and above. The antiviral is now approved in more than 70 countries for the treatment of influenza types A and B.
Roche said it is continuing to investigate Xofluza in phase 3 trials in children under the age of one, as well as to assess its potential to reduce transmission of influenza from an infected person to household members.