The European Commission (EC) has granted approval for Roche’s Xofluza (baloxavir marboxil) to treat and prevent influenza in children aged one year and above.
The single-dose oral medicine, Xofluza has been approved to treat uncomplicated influenza and post-exposure prophylaxis of influenza.
It has been designed to inhibit the cap-dependent endonuclease protein, which is said to be essential for viral replication.
In 2021, the medicine was initially approved in Europe for the same indication in adults and adolescents aged 12 years and more.
The latest regulatory approval expands Xofluza’s indication to include children aged one year and older.
The expanded EC approval of Xofluza makes it the first single-dose, oral influenza medicine approved for paediatric indication in Europe, said Roche.
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.”
The current EC approval is based on the data obtained from the Phase III miniSTONE-2 and BLOCKSTONE clinical trials.
In the miniSTONE-2 study, Xofluza reduced the time length by more than two days when influenza was released from the body compared to oseltamivir.
It was also well tolerated, with no new safety signals identified.
The medicine demonstrated a statistically significant prophylactic effect after a single oral dose compared with a placebo in the BLOCKSTONE study.
It also reduced 86% of the risk of people developing influenza after exposure to an infected household member compared with a placebo.
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