FDA Approves Xofluza to Treat and Prevent Flu in Children

The FDA has approved a supplemental new drug application (sNDA) for Genentech’s Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in children aged five to less than 12 years of age. Additionally, the FDA approved Xofluza for the prevention of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

“Despite the ongoing COVID-19 pandemic, influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems,”

Levi Garraway, M.D., Ph.D.

chief medical officer and head of global product development at Genentech, said in a press release.

The FDA approval is based on results from two phase 3 studies, miniSTONE-2 and BLOCKSTONE. miniSTONE-2 evaluated Xofluza compared with oseltamivir in otherwise healthy children and included patients aged five to less than 12 years with an influenza infection and displaying influenza symptoms for no more than 48 hours. BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. The results from these studies were published in The Pediatric Infectious Disease Journal and The New England Journal of Medicine respectively.

Adverse events reported in at least 5% of pediatric patients (ages five to 11 years) included vomiting and diarrhea.

Xofluza is available as a one-dose, single tablet. It is already FDA-approved to treat influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. It is also approved to prevent influenza in people 12 years of age and older following contact with someone with influenza.

Additionally, Xofluza is being studied in a phase 3 development program, including children under the age of one as well as to assess the potential to reduce direct transmission of influenza from otherwise healthy patients to household contacts.