Roche’s influenza treatment Xofluza (baloxavir marboxil) has expanded its indication to children aged one or older in Europe.
On Thursday (local time), the European Commission approved expanding Xofluza’s indication to treat uncomplicated influenza or prevent it after exposure to influenza in children aged one or older.
Xofluza won approval in Europe for treating influenza without complications in people aged 12 and older and preventing after exposure to influenza for the first time in 2021 and has since been used as a treatment for influenza A and influenza B in more than 70 countries.
With the latest expansion of indication, Xofluza can be sued to treat uncomplicated influenza in patients of all age groups, from children aged one to adults.
The approval was based on miniSTONE-2 and BLACKSTONE studies.
According to a miniSTONE-2 study that compared Xofluza and Tamiflu (oseltamivir), Xofluza drove out influenza from the human body in 24.2 hours, more than two days earlier than Tamiflu’s 75.8 hours.
Also, as a result of comparing Xofluza and placebo in various family members (adults and children) in the BLACKSTONE study, Xofluza reduced the risk of influenza infection after exposure to infected family members by 86 percent more than the placebo, demonstrating statistically significant prevention effect.
Roche continues to conduct clinical trials related to Xofluza through a phase 3 trial for children aged less than one, the NCT3653364 study, and the NCT03969212 study, which seeks to reduce influenza spread from infected people to their family members.
“EC has approved Xofluza’s use on children aged one and older because influenza can be particularly dangerous for children,” said Dr. Levi Garraway, Roche’s chief medical officer (CMO). “Roche hopes Xofluza's convenient one-time oral therapy will help children recover quickly and reduce the social burden of influenza.”
Xofluza is an antiviral drug with a new mechanism of action developed for the first time in about 20 years. It blocks the progress of viral replication from the early stage by inhibiting the acid endonuclease protein, which is essential for replicating influenza viruses.
The drug not only relieve influenza symptoms quickly with just one oral pill but also is effective in preventing transmission by reducing the time it takes to detect the influenza virus.