The drug called Xofluza, which is manufactured by Genentech, a unit of Roche-that already produces Tamiflu-announced the FDA approval covers the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older.
"A new antiviral against flu is of course welcome and is, at first blush, very attractive because it's one dose, " said William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine in Nashville.
"Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, told FOX Business previous year the reason for the massive outbreak-which was the worst since the 2009 swine flu pandemic-is because the virus had the dreaded H3N2 strain, which wasn't well-matched" with our current vaccines that were being distributed across the U.S.
Earlier this month the Centers for Disease Control and Prevention (CDC) had said that flu season has started for this year and last year many succumbed to the illness (around 80,000).
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Meanwhile, FDA Commissioner Scott Gottlieb also took the wind out of the new drug's sails somewhat by remarking in a press release that "While there are several FDA-approved antiviral drugs to treat flu, they're not a substitute for yearly vaccination", although he also said: "this novel drug provides an important, additional treatment option". Xofluza is to be taken within the first two days after the symptoms of flu appear.
Each year, more than 10 percent of the USA population gets the flu, and it can be very serious resulting in hospitalization or even death.
The drug, Japanese pharmaceutical company Shionogi's and Roche arm Genentech's Xofluza (or baloxavir marboxil), is different from existing medication in the sense that it attacks the virus through a different method.
Xofluza's safety and efficacy was demonstrated in two randomized, controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.
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CDC information website emphasize on the fact that flu virus is capable of rapid mutations and can soon become resistant to any drugs effective against it.
The 2017-2018 Northern Hemisphere flu season was especially bad, leading to some 900,000 hospitalizations, including 183 pediatric deaths, in the USA alone.
The drug inhibits the flu virus's cap-dependent endonuclease, thus distinguishing it from previously approved flu drugs including oseltamivir (Tamiflu), which target the viral neuraminidase protein. Its most common side effects include diarrhea and bronchitis. Extra research is planned to confirm whether taking Xofluza 10 days before exposure to flu can successfully stave off the respiratory infection.
Some experts are concerned it could lead to certain flu types developing antiviral resistance.
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