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.
"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical", said Gottlieb, a physician. "This novel drug provides an important, additional treatment option", said FDA Commissioner Scott Gottlieb, M.D.
Xofluza is a pill that can reduce severity and shorten duration of flu symptoms after one just dose.
Xofluza is not a substitute for the annual flu shot.
The treatment is the first new influenza drug with a novel mechanism of action that the FDA has approved in almost 20 years. (There was a third type of drug for the flu, but it was discontinued after 2016 as the influenza virus developed resistance against it.)"This is the most potent single agent that I've seen to date in terms of its effect on replication in acute influenza", Frederick Hayden, an infectious disease specialist at the University of Virginia, told STAT. Hayden worked on the drug for Shionogi, but his payment went to charity.Xofluza is a single pill that works by stopping the flu virus from replicating inside the body.
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Further testing is planned to determine whether Xofluza is better than Tamiflu for preventing spread of the flu to others and for treating patients at high risk for hospitalization and pneumonia, such as people with diabetes or lung disease, pregnant women, young children and the elderly.
It works about as well as Tamiflu, Roche's older flu treatment, which is also available in cheaper generic versions. It should be out in only a matter of weeks, according to USA Today and it's the first new flu drug in 20 years, reportsPopSci. Previous drugs took up to three days.
In company testing on 1,064 people, Xofluza ended coughing, sneezing and fever, or greatly reduced symptoms, in just over two days on average.
First, the most important similarity: Antiviral medications work best when they're taken within 48 hours of developing flu symptoms. There have already been a handful of deaths as a result of the flu so far in the United States, and past year the flu killed 80,000 individuals.The drug, known generically as baloxavir marboxil but sold under the brand name Xofluza, was invented and is manufactured by the Japanese company Shionogi & Co. There was no difference in the recovery time between Xofluza and Tamiflu. It's a prescription for that terrible moment when you get the bug but a doctor at Nebraska Medicine says it doesn't take away from the importance of getting a flu shot.