FDA expands approval of Genentech’s Xofluza for post-exposure prevention of influenza
pharmafile | November 24, 2020 | News story | Manufacturing and Production, Sales and Marketing | FDA, Xofluza, influenza
Genentech has secured FDA approval for Xofluza (baloxavir marboxil) for the post-exposure prevention of influenza in patients at least 12 years old. The decision makes it the first single-dose vaccine approved in the US to prevent flu infection after exposure.
The FDA based its decision on the review of Phase 3 data published in The New England Journal of Medicine. The data showed that the proportion of participants who developed influenza following exposure in the household was 1% in the group that received a single dose of Xofluza, compared to 13% in those receiving the placebo. Genentech said this was evidence of a “statistically significant prophylactic effect”.
The therapy was found to be safe and tolerable, with only mild side-effects reported.
“The flu is a serious illness that burdens households and sickens millions across the US every year,” explained 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.”
Genentech confirmed it now plans to pursue a label expansion for the drug with the FDA, seeking approval to treat acute uncomplicated influenza in otherwise healthy children, as well as for the post-exposure prevention of influenza children between the ages of one and 12.
Matt Fellows
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