FDA Expands Approval of Roche’s Xofluza for Influenza in Children Five to 12

The FDA has expanded its approval of Roche’s Xofluza (baloxavir marboxil) to include the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.

The FDA has also approved Xofluza for prevention through post-exposure prophylaxis of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

The drug was previously approved for these indications in adults. The expanded approvals were supported by positive data from two late-stage studies.

As the COVID-19 pandemic continues, “influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems,” said Levi Garraway, Roche’s chief medical officer and head of global product development.