FDA Approves New Flu Drug for the First Time in 20 Years as the Season Ramps Up

The FDA approved a new drug to treat the flu for the first time in 20 years, just as flu season starts

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For the first time in 20 years, there will be a new flu drug on the market.

The Food and Drug Administration announced on Wednesday that they approved a new antiviral drug, called baloxavir marboxil, which will be sold as Xofluza.

Xofluza is only approved for people aged 12 or older, and who have been feeling the symptoms of the flu for no more than two days.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Patients need just one dose of Xofluza, which will cost $150, Genentech, the manufacturer, told the New York Times, but they plan to offer coupons that bring the price down to $30 for people with insurance, and about $90 for those who are uninsured.


Currently, most doctors prescribe oseltamivir, or Tamiflu, to patients with the flu. But, as with most flu medications, the drug loses effectiveness as the flu builds up a resistance, and Tamiflu does not cure the flu very quickly. The drug is also costly, and can be anywhere from $100 to $350 based on the patient’s location.

But unlike past flu medications, Xofluza is formulated to block the enzyme that the flu uses to copy itself and spread, so it should be able to fight against strains of the flu that are resistant to the other drugs on the market.

However, experts still expect Xofluza to lose its potency over time as the flu builds up a resistance to the drug.

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“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” Dr. Debra Birnkrant, the director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said. “Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.”

Xofluza’s approval comes as the 2018-2019 flu season starts to ramp up. Several states, including Florida, New York and Connecticut, have reported the first deaths in their area of the season. Gottlieb emphasized that while new flu drugs are helpful for treatment, the best way to fight the flu is with vaccination.

“While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination,” he said. “Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

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