FDA approves first new flu drug in almost 20 years

A box of new flu drug Xofluza

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An exceptionally harsh U.S. flu season previous year resulted in more than 900,000 people getting hospitalized and more than 80,000 deaths, according to estimates here from the U.S. Centers for Disease Control and Prevention. "This novel drug provides an important, additional treatment option".

The U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October.

The medication is approved for people over the age of 12.

"This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in almost 20 years", said Scott Gottlieb, commissioner of the FDA. (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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Each year, an estimated 3-11 percent of the USA population gets the flu, and it can be very serious, resulting in hospitalization or even death.

"Tamiflu is given twice daily for five days, whereas the new drug is a single dose and then you are done", she said.

Beyond treating individuals and shortening the duration of flu symptoms, Xofluza has a potential public health benefit, says Deresinski. Both treatments have been found to greatly reduce flu symptoms in about two days on average.

Similar to Tamiflu, it needs to be taken within 48 hours of developing symptoms to be effective. It will cost $150 without insurance and will launch within a few weeks.

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While there are now "several FDA-approved antiviral drugs to treat flu", they're not a subsitute for the seasonal flu vaccine, Dr. Gottlieb said Wednesday.

The U.S. Food and Drug Administration (FDA) has approved a new antiviral treatment for the flu.

Genentech recently announced that the global Phase III CAPSTONE-2 study assessing the safety and efficacy of XOFLUZA in people at high risk of complications from the flu, as defined by the CDC, met the study's primary objective and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo. The flu can cause unsafe complications, so see your doctor as soon as you can if you start developing symptoms - especially if your symptoms are getting worse, or if you develop a fever of 103 degrees Fahrenheit or higher.

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