Genentech announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person.

Genentech, a member of the Roche Group announced that the FDA 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 (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. Post-exposure prophylaxis with single-dose Xofluza was evaluated in the Phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine. BLOCKSTONE 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. See-"Baloxavir Marboxil for Prophylaxis against Influenza in Household Contacts".- Hideyuki Ikematsu, M.D., Frederick G. Hayden, M.D., Keiko Kawaguchi, M.S., Masahiro Kinoshita, M.Pharm.,et al. July 23, 2020. N Engl J Med 2020; 383:309-320 DOI: 10.1056/NEJMoa1915341.