New weapon ready for launch at the flu

Grant Boone
October 28, 2018

The drug Xofluza was approved for patients 12 and older who have had symptoms for no more than 48 hours. "This novel drug provides an important, additional treatment option", Scott Gottlieb, MD, FDA commissioner said.

The 2017/2018 flu season in the US, according to the Centers for Disease Control and Prevention, was a high severity season with high levels of influenza-related clinic and emergency department visits and hospitalization.

For the first time in nearly two decades, the US Food and Drug Administration (FDA) approved a drug to combat the flu in people over 12 years old after symptoms have started.The approval, announced on Wednesday (Oct. 24), comes just in time for the ramping up of flu season in the northern hemisphere.

Of course, being a medication, Xofluza still has side effects-the most commonly reported ones were diarrhea and bronchitis, according to the FDA.

Every year, the seasonal flu virus infects 5 to 20 percent of Americans and can lead to tens of thousands of deaths.

"Having more treatment options that work in different ways to attack the virus is important, because flu viruses can become resistant to antiviral drugs", said Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research said in the FDA's statement.

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According to the medication's website, Xofluza is a newly FDA-approved prescriptionantiviral medication to treat the flu in anyone older than 12.

Xofluza was discovered by the Japanese pharmaceutical company Shionogi, and is being developed globally by the Roche Group (which includes Genentech in the United States) and Shionogi. Typically a person takes Tamiflu and Relenza twice a day for five days, in either liquid or capsule form.

Participants were assigned to receive either the drug, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.

The first new influenza antiviral for nearly two decades has been approved for use in the United States by its drugs safety watchdog.

Similar to Tamiflu, it needs to be taken within 48 hours of developing symptoms to be effective. The study was conducted in the USA and Japan by Shionogi & Co., Ltd. Many of us who get the flu may simply wait it out at home, but what you might not know is that drugs to treat the flu (and speed up your recovery time) are available. "The severity of last year's flu season underscores the need for new medical options beyond now available antivirals", he explained.

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