FDA approval of Roche's Xofluza in younger children

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche's (ROG: SIX) Xofluza (baloxavir marboxil) for 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, with the news edging the Swiss pharma major’s shares up 1.3% to 314.10 francs by late afternoon Friday.

This marks the first single-dose oral influenza medicine approved in the USA for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

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. The drug 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).