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FDA official says the approval is important because of the combination of the flu season and the COVID-19 pandemic.
FDA expanded the approved indication for baloxavir marboxil (Xofluza, Genentech) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.
In addition, the drug, previously available only in tablet form, is now available as granules for mixing in water, FDA said in a press release.
“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Americans will have to be more vigilant than ever as these viruses spread concurrently.”
Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
Xofluza’s safety and efficacy for post-flu exposure prevention is supported by one randomized, double-blind, controlled trial.
The trial included around 600 subjects who were exposed to a person with influenza in their household. The trial’s primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10. Of those who received Xofluza, 1% of subjects met these criteria compared with 13% of those in the placebo group.
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