What to Know About Xofluza, the New Flu Drug

Genentech  AP

Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

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". According to Centers for Disease Control and Prevention (CDC) estimates, a record 900,000 people were hospitalized and more than 80,000 died from flu last season. Other companies have worked with third-party vendors such as Crossover Health or One Medical to provide similar services. The approval is for people who are 12 or older.

"This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in almost 20 years", said FDA Commissioner Dr. Scott Gottlieb in a statement.

In fact, last year's flu season was so bad that Xofluza was granted priority review by the FDA, essentially expediting its approval from its usual ten months to six, to get that sh*t out to the public ASAP.

"This works by inhibiting, by preventing the replication, the duplication of the virus, so this is very different than the way the Tamiflu works", said Lenchus, "so that's what makes this relatively groundbreaking".

"Tamiflu is given twice daily for five days, whereas the new drug is a single dose and then you are done", she said. The treatment will cost $150, although patients with commercial insurance may be able to access the drug for $30.

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Regulators cautioned, however, that antiviral drugs to treat already developed flu symptoms aren't a substitute for vaccination.

On Wednesday, the Food and Drug Administration (FDA) inched closer to a record-breaking year of drug approvals, green lighting the first new antiviral flu medicine with a unique action mechanism in almost two decades. Both treatments have been found to greatly reduce flu symptoms in about two days on average. Those who are pregnant, plan to become pregnant, or are breastfeeding should also talk to their doctor before taking Xofluza, since its effects on an unborn baby or infants are unknown.

The prescription drug should only be taken within the first 48 hours of flu symptoms.

Share on PinterestThe development of the anti-flu drug Xofluza was announced earlier this year in Japan.

Dr. Lenchus said the drug is taken after a person is diagnosed with the flu.

Also, reminder: These drugs are meant to help speed up your recovery once you have the flu.

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