The FDA announced today that, Xofluza (baloxavir marboxil), a new flu medicine for people 12 and over will be available in just a few weeks.

The medicine needs to only be administered once and is to be used to treat those with uncomplicated flu that have been symptomatic for less than 2 days.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. 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,” said FDA Commissioner Scott Gottlieb, M.D.

The FDA Commissioner goes on to say that vaccination is the best way to avoid getting the flu:

“While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination. 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.”

When patients with the flu are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and duration of the illness.

“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,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.

So far, Maine's flu season has been reported by the Maine CDC as having started sporadically with 20 people testing positive for the flu, most being seen in Penobscot, Cumberland, York and Franklin counties.  Three of those testing positive have been hospitalized.

By the end of last year's flu season in May, the Maine CDC reported that there were over 9,000 confirmed cases of the flu with 1750 of those cases including hospitalizations and 92 deaths.

For more information about this medication and the FDA's announcement, see FDA.gov.

 

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