FDA Approves First New Influenza Drug in 20 Years
WEDNESDAY, Oct. 24, 2018 -- For the first time in nearly two decades, the U.S. Food and Drug Administration has approved a new type of antiviral influenza drug.
The single oral dose of Xofluza (baloxavir marboxil) is for the treatment of uncomplicated influenza in patients aged 12 years and older who have had symptoms for no more than 48 hours. When used within 48 hours of getting sick with influenza, antiviral drugs can reduce symptoms and duration of the illness, according to the FDA.
The drug's approval was based on two randomized controlled trials of 1,832 patients who received Xofluza, a placebo, or another antiviral influenza treatment within 48 hours of experiencing symptoms. In both trials, patients who received Xofluza had quicker relief of symptoms than those who received placebo. In the second trial, the time to symptom relief was the same for patients who received Xofluza and those who received the other antiviral treatment, according to the FDA. The most common side effects in patients taking Xofluza were diarrhea and bronchitis.
"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical," FDA Commissioner Scott Gottlieb, M.D., said in a statement. "This novel drug provides an important, additional treatment option."
Gottlieb noted, "While there are several FDA-approved antiviral drugs to treat flu, they're not a substitute for yearly vaccination."
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Posted: October 2018