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

Roche 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.

“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., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

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.

The approval is based on the results of the phase III miniSTONE-2 and BLOCKSTONE studies. The miniSTONE-2 study met its primary endpoint of safety and showed that Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir (viral replication; median time of 24.2 hours versus 75.8 hours, respectively). Xofluza was well tolerated with no new safety signals identified.

In the BLOCKSTONE study Xofluza showed a statistically significant prophylactic effect after a single oral dose, by reducing the risk of people developing influenza after exposure to an infected household member by 86% versus placebo (1.9% in participants treated with Xofluza and 13.6% in the placebo group).

Xofluza was first approved for use in Europe in 2021 for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in adults and adolescents aged 12 years and above. Xofluza is now approved in more than 70 countries for the treatment of influenza types A and B. Roche is continuing to investigate Xofluza in phase III trials in children under the age of one (NCT03653364), as well as to assess its potential to reduce transmission of influenza from an infected person to household members (NCT03969212).