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Baloxavir marboxil (Xofluza) can be used to prevent influenza illness in patients 12 and older who have been in close contact with an infected individual, the .

The drug thus joins oseltamivir (Tamiflu) in gaining a , though the latter's is broader in that the FDA approved its use in children as young as 1. Baloxavir has a unique mechanism of action, however. Whereas other flu antivirals including oseltamivir target the flu virus's neuraminidase enzyme, baloxavir inhibits its cap-dependent endonuclease.

In addition to conventional oral formulations, both drugs are also available in forms suitable for mixing in water -- granules for baloxavir, powder for oseltamivir -- enabling them to be taken by patients who can't swallow pills or capsules. Baloxavir was first approved in 2018 for treating active flu infections.

Baloxavir's new indication was supported by a randomized, placebo-controlled trial in 607 individuals living with someone with confirmed flu infection. The primary result was that 13% of the placebo group came down with flu, versus 1% of those given the active drug, the FDA said.

"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, MD, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research, in a statement announcing the approval. "Americans will have to be more vigilant than ever as these viruses spread concurrently."

The FDA granted the new indication to Genentech (which also markets Tamiflu), although the drug was originally developed by Japan's Shionogi & Co.

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