Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (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.
“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We’re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic.”
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.
“The flu is a serious illness that burdens households and sickens millions across the U.S. every year,” said Serese Marotta, Chief Operating Officer at Families Fighting Flu. “As we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.”
The most frequently reported adverse events (occurring in at least 1% of adult and adolescent influenza patients treated with Xofluza) included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).
Additionally, Genentech 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.