Roche announces Xofluza to treat influenza in children has been FDA approved

Roche announced that a supplemental New Drug Application for Xofluza for the treatment of influenza in otherwise healthy children from ages five to twelve who have been symptomatic for no more than 48 hours has been FDA approved. This is the first oral single-dose influenza medicine for children in this age group in the US. In addition, Xofluza has been FDA approved for the prevention of influenza in children aged five to twelve following contact with someone with influenza.
Levi Garraway, Ph.D., Roche’s Head of Global Product Development and Chief Medical Officer, has said, “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. Xofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents, and we are pleased to now offer households and younger children our single-dose oral treatment.”
Influenza can be a serious illness for young children. Despite a period during the COVID-19 pandemic where significantly fewer influenza cases where seen, largely due to social distancing and mask-wearing, in the US 2018-19 influenza season, there were over 100 deaths among children, thousands of hospitalisations and over six million illnesses caused by influenza.
The results of 2 phase III studies, miniSTONE-2, evaluating the use of Xofluza in children, and BLOCKSTONE, evaluating Xofluza as a preventive treatment for household members, encouraged the approval from the FDA.