Roche Xofluza bags USFDA okay for influenza treatment in children aged five years and older

According to the U.S. Centers for Disease Control and Prevention, influenza can be a serious illness for young children. During the ongoing COVID-19 pandemic there have been significantly fewer influenza cases, likely due in large part to social distancing and mask wearing. However, in the US 2018-2019 influenza season, there were more than 6 million illnesses, thousands of hospitalisations and over 100 deaths among children aged five to 17 caused by influenza.

"Historically, school-aged children have played a significant role in the community transmission of influenza. 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," said Dr. Pedro Piedra, miniSTONE-2 Study Investigator and Professor of Molecular Virology, Microbiology and Pediatrics at Baylor College of Medicine. "The FDA approval provides children with a single-dose antiviral option, Xofluza, to treat influenza."

The FDA approval is based on results from two phase III studies: miniSTONE-2, which evaluated the use of Xofluza in children, and BLOCKSTONE, which evaluated Xofluza as a preventive treatment for household members, in both adults and children. The results from these studies were published in The Pediatric Infectious Disease Journal and The New England Journal of Medicine respectively.

Xofluza 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. Xofluza is also approved to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is available as a one-dose, single-tablet.