The flu season continues to lead to new cases and hospitalizations, but clinicians in Europe now have a new tool to try to stop the virus in children. It is now Roche’s antiviral flu medicine for adults and adolescents approved for those aged 1 and over.
The European Commission has approved Roche’s drug baloxavir marboxil to treat uncomplicated flu, which is a sudden onset of symptoms of the infection but without the need for hospitalisation. The approval announced Thursday also covers flu prevention in those who have been exposed to someone who has it. The regulatory decision for the drug, which is marketed as Xofluza, is consistent with its currently approved uses in Europe for adults and adolescents.
Xofluza is a tablet taken as a single dose. The small molecule works by blocking a flu-specific enzyme that the virus uses to replicate. The committee’s approval decision was based on the results of two phase 3 clinical trials. One of the trials compared Xofluza with Tamiflu, an older and now generic antiviral drug that Roche sells. The results showed that the average time to relief of flu signs and symptoms in infected patients was 138 hours for Xofluza and 150 hours for Tamiflu. Compared to Tamiflu, Xofluza also reduces by more than two days the length of time it takes for influenza to be cleared from the body.
The second phase 3 trial tested the drug’s ability to prevent the spread of influenza. The study assesses household members, children and adults who live with someone with a confirmed case of the flu. Participants were randomly assigned to receive study drug or placebo. Roche said clinical trial results showed that, compared to placebo, a single oral dose of Xofluza resulted in an 86% reduction in the risk of developing influenza after exposure to an infected household member.
In both studies, Roche reported that Xofluza was well tolerated by patients and no new safety signals were identified. Side effects reported in tests of the drug in adolescents and adults included diarrhea, bronchitis, cold symptoms, headache and nausea.
“We hope that the convenient, single-dose oral regimen of Xofluza will help children recover quickly as well as reduce the public burden of influenza,” said Levi Garraway, Roche’s chief medical officer and head of global product development, in prepared statement.
Xofluza was discovered by Japan-based Shionogi. In 2016, Roche licensed global rights to the drug, except for Japan and Taiwan, where Shionogi retains the rights. Xofluza won its first approval in Japan in 2018. Later that year, the FDA approved the drug to treat patients 12 years and older. Last August, FDA expanded the approval of the drug for those aged 5 years and older.
The first European approval of Xofluza came in 2021 and covers adults and adolescents aged 12 and over. Roche says the drug is already approved in more than 70 countries to treat influenza A and B. Phase 3 testing is ongoing in children under 1 year of age, as well as to further evaluate the drug’s ability to reduce transmission among household members.