FDA: New Influenza Treatment

The US Food and Drug Administration has approved baloxavir marboxil (Xofluza) for the treatment of acute uncomplicated influenza in patients aged 12 years or older who have been symptomatic for no more than 48 hours.


The approval comes after 2 randomized clinical trials evaluated baloxavir marboxil, placebo, and another antiviral flu therapy among patients with flu symptoms within the last 48 hours (N = 1832).


Results showed that baloxavir marboxil reduced the time to symptom alleviation compared with placebo.


The most common adverse events reported were diarrhea and bronchitis.


“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, MD.


—Amanda Balbi



FDA approves new drug to treat influenza [press release]. Silver Spring, MD: US Food and Drug Administration; October 24, 2018. Accessed October 24, 2018.