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For the first time in 20 years, a new flu drug will be on the market.
The Food and Drug Administration announced Wednesday that it has approved a new antiviral drug called baloxavir marboxil, which will be sold under the name Xofluza.
Xofluza is approved only for people 12 years of age and older who have been experiencing flu symptoms for up to two days.
"This is the first new antiviral treatment for influenza with a new mechanism of action approved by the FDA for nearly 20 years," said Dr. Scott Gottlieb, FDA Commissioner, in a statement. "With thousands of people contracting the flu each year and many people becoming seriously ill, it is essential to have safe and effective treatment alternatives. This new drug is an important additional treatment option. "
Patients only need one Xofluza pill, which will cost $ 150, said Genentech, the manufacturer, at New York Timesbut they plan to offer coupons that bring the price down to $ 30 for insureds and about $ 90 for uninsured people.
Currently, most doctors prescribe oseltamivir, or Tamiflu, to patients with influenza. But, as with most flu medications, the drug loses its effectiveness as the flu acquires resistance and Tamiflu does not cure the flu very quickly. The drug is also expensive and can range from $ 100 to $ 350, depending on the location of the patient.
But unlike earlier flu medications, Xofluza is formulated to block the enzyme used by the flu to copy and spread. It should therefore be able to fight against strains of the flu resistant to other drugs available on the market.
However, experts still expect Xofluza to lose its effectiveness over time as the flu increases its resistance to the drug.
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"When treatment is started within 48 hours after the onset of flu symptoms, antiviral medications can reduce symptoms and shorten the times patients feel sick," said Dr. Debra Birnkrant, Director. of the Division of Antiviral Products Center for Drug Evaluation Research, said. "It's important to have more treatment options that attack the virus in different ways because the flu virus can become resistant to antiviral drugs."
Xofluza's approval comes as the 2018-2019 flu season begins to intensify. Several states, including Florida, New York and Connecticut, reported the first deaths in their area of the season. Gottlieb pointed out that although new anti-influenza drugs are useful for treatment, the best way to fight the flu is vaccination.
"Although there are several antiviral medications approved by the FDA to treat the flu, they do not replace the annual vaccination," he said. "The flu season is already well advanced and the US Center for Disease Prevention and Control recommends getting vaccinated by the end of October, as the seasonal flu vaccine is one of the ways the most effective and safest to protect yourself, your family and your community. influenza and serious complications related to influenza that can lead to hospitalizations. Annual vaccination is the main means of preventing and controlling influenza epidemics. "
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