FDA Approves Flu Treatment for Post-Exposure Treatment

The FDA expands the approval of the flu treatment Xofluza to include prevention of the virus after exposure.

The FDA expanded its approval indication for Xofluza, a medication that combats the flu, on November 23.

The approval now includes post-exposure prevention of the flu for patients who are 12-years-old and older after they have had contact with someone who has the flu. The drug, which was first approved in 2018, is now available as granules that can be mixed in water instead of the usual tablet form.

“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.”

During the trial for the drug—which included 607 subjects—1% of the subjects who were given Xofluza were infected with the flu at the end of the trial. Thirteen percent of subjects that contracted the flu had been given a placebo.

For more information, visit fda.gov.

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    April 2021

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