Roche have announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza. Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.
Post-exposure prophylaxis with single-dose Xofluza was evaluated in a phase III study that evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified.
Roche says it is determining a path forward with the FDA for a potential indication for Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population.
Xofluza is already FDA-approved to treat acute uncomplicated 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.
Read the FDA statement