The EC approval expands Xofluza’s indication in the EU to include the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adults
Roche administration and R&D buildings. (Credit: F. Hoffmann-La Roche Ltd)
Roche has received the European Commission (EC) approval for Xofluza (baloxavir marboxil) to treat and post-exposure prophylaxis of influenza in children aged one year and above.
The post-exposure prophylaxis refers to the prevention of influenza in individuals after they contact others who are infected with the influenza virus.
Xofluza is a single-dose oral antiviral, designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.
In 2021, the drug was initially approved in Europe for the treatment of uncomplicated influenza and the prevention of influenza in adults and adolescents aged 12 years and above.
The current EC approval expands its indication to include children as young as one-year-old.
Xofluza is already approved in more than 70 countries, to treat influenza types A and B.
With the expanded EC approval, Xofluza becomes the first single-dose, oral influenza medicine approved in Europe for paediatric indication, said the Swiss drugmaker.
Roche chief medical officer and global product development head Levi Garraway said: “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.
“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.”
Roche said that the EC approval is supported by results from the Phase 3 miniSTONE-2 and BLOCKSTONE clinical trials.
In the miniSTONE-2 study, Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir.
The study met its primary endpoint of safety and showed that the drug 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, compared to a placebo.
The drug helped in reducing the risk of people developing influenza after exposure to an infected household member by 86% versus placebo.
Roche said that it will continue Phase 3 Xofluza trials in children aged below one year, and evaluate its potential to reduce transmission of influenza from an infected person.
Xofluza was originally discovered by the Japanese pharmaceutical company Shionogi and is being further developed and commercialised jointly by Roche and Shionogi.