FDA Grants Influenza Drug Xofluza Expanded Indication

The FDA has granted expanded approval for Genentech’s influenza antiviral drug Xofluza (baloxavir marboxil), allowing its use for post-exposure prevention of the flu in patients aged 12 and older.

The drug is now approved for patients who have been in contact with another person who has the flu. The expanded indication “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, director of antiviral products for the FDA’s Center for Drug Evaluation and Research.

Xofluza was first approved in 2018 for treating uncomplicated flu in patients 12 and older who have been symptomatic for no longer than 48 hours. In addition to its original tablet form, Xofluza is also now available in granule form for mixing in water.