FDA approves Xofluza for treatment of influenza in children 5 years and older


Xofluza is now the first single-dose oral medication for influenza approved for children aged less than 12 years.

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavirmarboxil; Genentech, Roche Group) for the treatment ofacute uncomplicated influenza in children aged 5 to 12 years within the first 48 hours of symptoms. Before now, no single-dose oral influenza medication had been approved for children in this age range.

The Centers for Disease Control and Prevention has discussed the dangers of influenza in young children, as over 6 million cases, thousands of hospitalizations, and over 100 deaths took place in children during the 2018-2019 influenza season. There have been less cases in following seasons, though this is most likely because of social distancing and masking during the COVID-19 pandemic.

Pedro Piedra, MD, miniSTONE-2 study investigator and professor of molecular virology and microbiology, statedinfluenza is commonly spread by school-aged children. “The annual influenza vaccine continues to be the most important first step to prevent illness in children, though there can still be breakthrough cases where antiviral treatment is needed,” he said. “Today’s FDA approval provides children with a single-dose antiviral option, Xofluza, to treat influenza."

The FDA approval is supported by data from 2 phase 3 studies. The first, miniSTONE-2, compared Xofluza with oseltamivir in children with influenza who were otherwise healthy. The second, BLOCKSTONE compared Xofluza with a placebo for both children and adults living with a family member who had influenza.

Xofluza is already used in individuals aged 12 years and over to prevent influenza after contact with someone who has contracted the disease. It is also used for individuals of this age range who are otherwise healthy and have experienced symptoms for less than 48 hours. 

The single dose, oral medication has proven effective in a wide range of influenza viruses. It hinders cap-dependent endonuclease protein which causes the spread of biological viruses. This has made it an important tool against influenza since its first FDA approval in October 2018.

Pediatric patients taking Xofluza experience adverse events such as vomiting and diarrhea in 5% of cases. Bronchitis, nausea, sinusitis, headaches, and potential allergic reactions have been recorded side effects of Xofluzain the past.

Xofluza will continue to be codeveloped by Shionogi & Co., Ltd. and the Roche Group. Another phase 3 development program is currently testing for use of the medication in children under the age of 1 year. Currently, Xofluza is not approved for use in children aged less than 5 years.


Genentech announces FDA approval of Xofluza to treat influenza in children aged five and older. Business Wire. August 11, 2022. Accessed August 12, 2022. https://www.businesswire.com/news/home/20220815005009/en/Genentech-Announces-FDA-Approval-of-Xofluza-to-Treat-Influenza-in-Children-Aged-Five-and-Older

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